Moderna

Sore arm, fatigue,chills ,nauseousness ,vomiting on 12/292020 . Chills ,nausea, vomiting started around 6 pm

Awoke with nausea and myalgias. Nausea and myalgias progressed. Fever and chills within a few hours. Very weak and fatigued. Myalgias became severe. Severe rigors and fever >102 about 26 hours post vaccine. Fever, myalgias, anorexia, nausea lasted approximately 30 hours. I felt like I had COVID all over again (I had it in July).

Started with fatigue,. chills, fever up to 100.3, muscle aches, severe chest discomfort , heart rate up to 130 . Is an EMS provider, went to fire house and EKG was normal, just elevated heart rate and BP around 130/80 Fatigue - resulting in lack of eating /appetite

Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm

Woke up that night feeling achy and run down. Had a low grade fever, headache, nausea for most of the next day after the injection. Two days later developed swelling and lymphadenopathy on same side for several days treated with NSAID's to help with inflammatory response. It is better now but some minor swelling still present but mostly resolved.

Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative: employee was told to follow up with his physician and get tested for covid

c/o severe headache & generalized body aches; Temp 100.8; dizzy/faint symptoms relieved by Tylenol 1000 mg PO. after lasting from 1/8/21 - 1/9/21

Sore arm for 36 hours. Onset within an hour after recieving the vaccination, Slight malaze for 24 hours. Onset the next morning post vaccination.

Approx 26 hrs post injection, uncontrollable rigors. Left work early and off flowing day. Crawled in bed under covers. Later che led temp. Fever 103.2. Never in my life. Drank 6 cans gatorade to avoid dehydration. Next morning fever 102.4. Got up strength later to pack clothes and drive home. Back in bed. Reported to my PCP. Felt adverse reaction to vaccine and consulted doc. By third morning all symptoms has essentially dissipated.

01/9/2021 sweats/fever like I had Covid 19 again. on01/10/2021 sore and swollen under right armpit and swollen neck.

1. Incontrollable Shaking of body and limbs-- for 2 days, 2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days

Began to feel ill ( stomach pain / Headache ) .. my skin became flushed ( face was very red ) blood pressure was elevated ( 180/90) I normally have low BP.

Low grade fever (99...typical is 96-97 for me), intense lower back pain and headache. Also, lethargy and a heaviness to my breathing when exercising.

Temp 100.7 F, chills, generalized body aches, and excess fatigue. Onset of symptoms occurred in the early morning hours the day after receiving the vaccine. Symptoms completely resolved by the next morning. Treatment was conservative with Tylenol, rest, and hydration. I missed one day of work due to this brief episode. I am a SARS COVID survivor who had a very severe / life threatening case of SARS COVID 19. I was hospitalized and treated from March 28, 2020 to May 16, 2020. Please feel free to contact me for any information that you may need.

Chills, muscle ache, nausea, headache 1/21/21 took tylenol at 3:30am and again at noon. Most symptoms went away by morning. General muscle ache continued through out the day. Morning of 1/22/20, all symptoms gone except for a little ache in right arm.

Felt like a wasp sting at injection, very euphoric 8 minutes later and began the sweats, face is flushed and full feeling and medium headache

Mild fatigue, general aches & pains, very sore shoulder at injection site, chills, difficulty sleeping due to muscle aches.

Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise. Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained. Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours. Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms. I often work through illnesses like the flu. Couldn?t work through this.

Approx 24 hours after receiving the vaccine on I experienced joint pain that was not associated with the injection site. Within 48 hours I experienced flu-like symptoms (body aches, low grade fever of 100.1, chills) and then overnight experienced sweats . Woke up the following morning feeling better and now, 72 hours after receiving the vaccine, I am no longer experiencing any side effects.

Moderna COVID?19 Vaccine EUA. On the day after my shot, injection site muscle pain, nausea, flu-like symptoms throughout the day.

Moderna COVID-19 Vaccine EUA Had chills during night. Took Naproxen with some relief. 12N had uncontrolted shaking and chills and malaise, unable to handle mouse to do work. No redness, swelling or irritation of injection site. Extremely tired.

Full Body aches, headache, extreme body chills, and extremely tired. Slept a great deal . Lasted 24 hours.

Approximately 5 hours after my injection, I started to feel fatigue. Went to bed, awoke around 0039 1/26/2021 with mild shortness of breath and slight chest pressure. Around 0500 I started with chills, muscle, joint, bone pain. I went back to bed and awoke around 1200 with throat tightness, SOB, chest pressure and diaphoretic accompanied by the other symptoms. I went to my local ER.

C/0 feeling "hot flashes" an hour after vaccination given. As the evening progressed C/O joint aches, HA, low grade temp (99.8 F at 6 p.m., muscle cramps and restlessness during the night (2 a.m.) and feeling of "electrical shocks" in his muscles. 1/27/21- C/O joint pain HA and muscle cramps-took gabapentin and Tylenol and feeling better. 1/28/21 Able to work, feeling better, but not 100% yet.

The following day 1/29/2021, I started with chills and then later night sweats. I also had headaches. Saturday1/30/2021, I had muscle pain and joint pain throughout my body most notably in my right knee and right hip. Today, Monday 2/1/2021, my rib cage is sore with muscle pain.

After second Moderna shot, Pt developed nausea, headache, extreme fatique, and bad back and leg cramps/spasms to the point where he couldn't walk. These symptoms lasted for 48 hours and gradually subsided. His wife (me) was so frightened that I will not be getting the Moderna series since it's so dangerous and will caution friends and family as well.

body flushing, fatigue, and itchiness of his right arm accompanied by intense over his entire left arm. Patient felt his body getting overheated

Next day chills, body aches, headache, diarrhea, fatigue. These symptoms had resolved by the 2nd day post-injection.

I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 hours afterwards) with severe chills, shoulder, knees & most joints aching badly, bones in both feet aching with any movements, both arms sore along with severe stomach cramps & nausea, these all lasted through the night and day with a fever of 101 at 7am but by 4pm all but the stomach cramps were replaced by just nausea but severe headache and weakness all over were felt. I remained in bed until about 4pm 2/5/21 & soaked in a hot bath which relieved the joint pains. Headache, nausea & weakness continued 2/6/2021 & 2/7/2021 with the headaches coming if any sudden movements such as coughing or standing up too fast & nausea irritated by eating anything but saltine crackers. Today is 2/7/2021, took sick days from work 2/5, 2/6 & 2/7.

Chills, sweats, fatigue ("horrible"), headache, body aches, slightly dizzy, could not get up and do anything. still with body aches and fatigue 3 days post vax.

Aches, chills, typical flu type symptoms, Fever to 102 F. Lasted till about midnight. Fever broke and felt fine afterwards. Also had pain in arm on both shots. Worse the first night then less each day for about 3 days.

Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint pain, fatigue, mild cough, temperature elevated but not high, about 99 degrees. Symptoms varied over about 24 hours then subsided. Injection was Friday morning, Friday night not much sleep due to symptoms, all day Saturday in bed, slept well Saturday night, and Sunday fatigue and achiness only.

Extreme untreatable Headaches, burning sensation left side of body, backache left side, Eye Pain and sudden onset of shingles.

Rash on inner wrists, upper thighs and scrotum along with 100 degree fever awoke me around 3:00am Feb 6. At 7:06 am I noticed left side facial swelling and slightly obstructed throat. Swelling worsened only slightly from 7am to 9am. At 9am I took 100mg Benadryl and withing 45 minutes swelling was subsiding and breathing was normal. Arrived at ER at around 11:am. Was treated with EPINEPHrine, methylPREDNISolone and saline IV. Released after a few hours

Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.

Moderna Covid 19 Vaccine EUA patient complains of low grade temp 99-100. Had sweating, fatigue, headache, felt like he was "hit by a truck". Took Tylenol every 6 hours as needed for symptoms.

The arm where the shot was administered, underneath the armpit area was swollen (Lymph Nodes) also had body aches, slight fever.

Temperature of 100.6 with chills, fatigue and sore arm; Adverse reactions have gone away by 9:00 am Friday, Feb 12, 2021

Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack. On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG) – results not provided. The patient also stated he had blood pressure issues but did not provide any further information. On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding. Treatment for the event included surgery. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Headache, fever, body aches, nausea, fatigue, lethargy, injection site pain over first 12-18 hours. Fluids only for treatment

Chills began approximately nine hours after injection; temperature normal; treated with ibuprofen and sleep. Following morning fever rose to 101 F, chills persisted, with widespread muscle aches and general torpor. Treated with acetominophen. Vomited once at approximately 9:30 a.m. Fever and chills ended approximately 26 hours after vaccination. Extreme fatigue/torpor persisted until roughly 52 hours post vaccine. Condition normal by 60 hours post vaccine.

On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7, CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.

Since 12 Feb to present I have had aching bones and joints alone constant fatigue and general weakness in my left arm.

Fever (102.7), headache, soreness of arm, lymphnode swelling (axilary), tea colored urine (prior to rehydration), cotton mouth. Tx: ACTM PRN over 3 days for fever, Increased fluids

Headache, nausea, muscle pain, dizziness, fatigue, cognitive issues, fever/chills I'm taking Tylenol but don't know if it's doing much. Symptoms are ongoing I may go into my doctor's office if symptoms persist.

muscle/body ache, bad headache, pain, redness, and swelling at injection site approximately the size of a grapefruit, nauseated, neck swelling.

Fever and diaphoresis 2/12/21, followed by neck pain starting 2/13/21. Hospital admission with sepsis with right-sided cervical lymphadenitis without abscess 2/17/21. Treated with Unasyn.

2/18/2021 fever 100.5 and scratchy throat 2/20/21-Covid test positive. No contact with covid positive, patient is still admitted in the hospital from December. 2/20/21 patient was drowsy, lung sounds rhonchi, Respirations 36, O2-78 % on room air. 4L per NC applied.

Chills, joint pain and slight pain in bones. went to bed at 10 PM with chills, at midnight severe sweating. 5 AM woke with pains in joints and bones. Took three Tylenol extra strength. Woke at 8 AM, took two more Tylenol. Currently at 10:30 AM feel OK, a little tired from lack of sleep. most symptoms gone.

At 0600 on 23 Feb I woke up with a temp of 101.9 (normally, I am at 97.4) headache, stuffy head, body ache and a sore arm at the injection site. I had elevated temperatures for the next 24 hours. Headaches also lasted 24 hours. Also, this was accompanied by fatigue. Even the slightest exertion winded me.

Injection site: tenderness and swelling of the lymph nodes in the same arms as the injection. General side effects: fatigue, muscle pain, fever (100.2)

102.4 fever, body aches from the back of my neck to the back of my ankles, fatigue, throbbing migraine, no appetite

-Severe soreness in injection area lasting 3-days -101 fever starting 18-hours after vaccination and lasting 10-hours -Fatigue of whole body lasting 3-days -Loss of appetite lasting 2-days -Acute soreness in both shoulders that have existing tendonitis and in right ankle that has existing arthritis lasting 2-days -Internal lower abdominal pain starting 2-days after shot and lasting 24-hours

Sore arm. Headache. Dizzy 7pm same night. Didn't sleep well. Achy especially in knees and back. 3/7 am slight fever 100. Headache all day. Still sore arm. Body ache, no appetite.

Uncontrollable shaking as from chills, fever up to 101.6 (possibly was higher before checking), fatigue, no interest in food or drink. Symptoms came on quickly, and subsided in 8-9 hours. (Almost exactly 24 hours after the shot.)

"Fever > 100.4:Y, 101.4evening past 3 nights. @ 8-9 pm. Subjective fever: Chills:Y Rigors:N Myalgias:N Headache:N Sore throat:N Diarrhea:N Nasal congestion/rhinorrhea:N Additional symptoms:No rash No fatigue no dysuria Onset and duration: 3/3/2021"

Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the area of the heart. Went to ER and was given EKG, Chest X-Ray, and blood tests to check for heart attack. Symptoms subsided after a bit. Labs were inconclusive. Sent home. Continued to have lingering aching in the heart region the next day. Throughout the weekend, continued to experience alternating sweats and chills, nausea and increased pain in hip joints causing difficulty to walk. Stayed home from work on Monday, March 8, 2021 with the same symptoms continuing. Tuesday, March 9, 2021 began experiencing excruciating thigh and knee pain to the point of barely being able to stand or walk. Returned to the ER where they administered Torodol and pain subsided. Will be seeing primary care physician Tuesday afternoon.

pt states that his arm was sore that day of the vax but when he woke up he had body aches and pain, fever and massive headache. Pt is taking Advil. Pt has contacted his PCP regarding his symptoms and is waiting for a CB.

pt states he felt fine until about the 10th day 3/8/2021 he started getting flu like symptoms. He has SOB, diarrhea, headache, sweats, muscle pain, cough, chills, and fever. On 3/11/2021 pt is still having these symptoms but is feeling a little better. Pt is taking Robitussin, Aleve, Vicks Av.

Moderna COVID- 19 Vaccine EUA: Three days after vaccination patient reported rash on chest, back, and legs. No itching reported. Patient advised to use antihistamines if itches and to return to clinic as needed. Two days later patient reports rash has not improved and has developed runny nose, sneezing, nasal congestion, mild cough, and cold symptoms: denies itching, fever, sore throat, shortness of breath, changes in taste or smell, and pain. Patient diagnosed with mild COVID-19 and being managed at home.

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.

Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats

Extreme fatigue followed by muscle aches, mostly in upper thighs and knees, headache and fever reaching 102 Began at approximately 15:00 on 3/9/21 lasting approximately 12 hours. No adverse effects since

Starting the morning after shot when I got up at 4.00am I was having reactions to the shot. Hot, Cold, Headache , muscle pain, tired, nausea, loss of appetite like a bad case of flu. also which has been the biggest most unexpected side effect is that my left testicle was swollen and painful. All my flu like systems continued as well thru Wednesday 03/10/2021. started feeling some better except for being tired and the swelling and pain in testicle. Thursday morning went to Urgent Care, did examination with urinalysis and thought possible infection. Recommended ultrasound and prescribed Doxycycline HYC 100MG, also Ibuprofen 800mg.

about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn't slrrp took benadryl called 911 they came and took my vitals highblood pressure a fever of 101 it wasn't to bad so they left i stayed awake all night and started to feel better the next day

Pain, redness, swelling at injection site since day of vaccination. Also fatigue; sleeping 10-12 hours per night since vaccination date.

Day 1 within 4 hours intense burning in arm at site of shot lasting for 3 days. Day 2 to current time(day 6) swelling of hands and feet. Day 2 to current time (day 6) burning / itching / small red spots on face and behind ears that eventually dried up and peeled . Peaked at day 3. Still very irritated and raw but intense itching has subsided. Day 5 extreme fatigue and minor headache preventing me from working.

patient stated experienced "labored" breathing and he took himself to the ER. did not experience rash, itching, hives, swelling of mouth, lips, or throat. Pt is also experiencing severe nausea and headache. Patient was instructed if continued to experience labored breathing to reach out to his primary care provider or seek medical attention. Patient did not have any reaction to first dose in series.

Up and down persistant fever with very bad chills for 2 days straight on Sunday and Monday 3/14- 3/15/2021. Also accompanied by very bad body aches and pain in my left arm. Left arm pain radiated to left axilla. Strong headache for three days 3/14-3/16/2021. Left arm still hurts on 3/17/2021

Fever/ Chills/ Pain in my whole body/ Sicker than I was ever before in my life. Lose of Memory. Head Aches/ Leg pain that wasn't there before vaccination.

THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE. THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK. HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE. PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021. HE WAS DISCHARGED HOME IN STABLE CONDITION .

pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection

Fever up to 102.8 that is not lowered with Tylenol, significant bilateral knee pain, and redness at vaccine site. Was seen in the ER and advised to "Take ibuprofen ( 3 Advil tablets) 600 mg every 6 hours. In between you can also take acetaminophen (2 Tylenol extra strength) 1000 mg every 4 hours . For example Ibuprofen 600 mg at 8pm. 2am, 8am 2pm regularly Then can take tylenol in between those doses if needed. Drink fluids well." Follow up call to patient on 3/19/21 "States he is feeling better today. Has been taking Ibuprofen which is controlling his fevers. Does not think he has a fever at this time. States I sweat it all out last night. No questions or concerns."

Fever chills body aches headache tired. Sleep excedrin migraine and cold was cloth on forehead. Fever and chills lasted 12 hours. Aches and tired lasted much longer

20 hours after vaccination, Pt began feeling unwell. He was tired, his body hurt, and he had the chills. He came home from work, got into bed with a heated blanket (teeth chattering) and fell asleep. He woke a few times to urinate and drink water, but slept for 16 hours. He kicked off the heated blanket after 2 hours.

Fever of 103.5, chills, headache, body aches all over. Took naproxin, applied cold compresses, sleep. Resolved within 24 hrs.

The day after the shot 3/9/2021 pt had 104 degree fever and shortness of breath and chest pain. This continued for a couple days. By 3/13/2021 pt went the hospital and he was confirmed to be having an active heart attack.

Vaccination on Wednesday. Felt normal fatigue and pain Wed/Thu/Fri. Felt completely fine Fri evening and Saturday. Woke up Sunday with severe dizziness and slight ringing in ears. Rest didnt help. Took Benedryl and seemed to get better in the night. Woke up Monday again with dizziness. Slightly better but still not able to work or do activities. Pharmacy referred to Physician - waiting for that appointment.

I?ve experienced severe fatigue, daily elevated temperatures, occasional nausea, headaches and muscle aches.

Morning after injection. Severe flu like symptoms including nausea chills fever muscle/joint pain pain at injection site sore throat and runny nose. Took ibuprofen for fever and body pain. Next morning body aches runny nose sore throat and a full body rash that did not itch.

On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine. Afterward, the patient experienced no adverse side effects. About 48 hours later, however, at 2pm on March 18th, the patient's spouse attempted to wake him from a nap. The patient seemed much groggier than normal and his expression appeared vacant. When pressed by his spouse, the patient could not say who he was, or who his wife was. He agreed to travel with his wife to the hospital. At the hospital, a healthcare professional asked the patient who he was. He answered with his correct name. He also correctly identified his spouse by name. But when asked where he was, the patient gave a long and incoherent response. After this initial screening, doctors at the hospital evaluated the patient for a stroke. They ruled this out as a possibility. Next, they suspected the patient's MS lesions may have contributed to his "cognitive event." However, after comparing his 2018 scan to a current scan, they determined this was unlikely the cause. After about 24 hours at the hospital, a neurologist hypothesized that the patient had experienced a seizure. Another doctor at the facility concurred with this assessment. By late Friday (more than 24 hours after the episode), the patient had regained most of their cognitive functioning, though he still experienced mild confusion around the week's events (even preceding the "cognitive event"). Prior to now, the patient has never had a seizure before.

This is a 60-year-old male who comes in today (3/22). Patient states that he received a Covid shot 11 days ago since then he has had mild fevers. However 6 days after he received his Covid vaccine he developed a fever of 102 he has been alternating between Advil and Tylenol without any improvement of his symptoms. Patient states that he now is having a difficult time breathing he has some nausea without any vomiting but has had a difficult time eating without any abdominal pain no diarrhea. Has had generalized myalgias as well. He denies any large cough states that he is coughing a little bit. No chest pain. Patient tested positive for Covid 19. Is now admitted and on oxygen.

after having mild heachache and fatigue the day of the vaccine, I woke at 2:00 am with searing gout pain in my right knee. First severe gout flare up in 18 months, I take allopurinol and get gout in both ankles, right knee and right big toe. At approximately 3:30 am started feeling gout starting in the left ankle and took Indomethacin. Pain started to subside around 7 am, took another Indomethacin at 9 am. by noon started feeling close to normal with some fatigue. I cannot think of any of my gout triggers in the past week that could cause the attack. Did not see possible gout flare up as a side effect until I researched the web as my knee was on fire.

Arm sore for a week Hurt into chest Felt extremely fatigued for about 5 days. Ran fever over 100 for 2 days. Felt fine after 5 days.

This may be purely coincidence, but the reaction was so severe, I thought you should have the puzzle piece. On March 23 I donated blood. Within 30 minutes I had a fever of 100.9, was extremely weak and sleepy, had the worst sore throat and radiating down in my memory. It was difficult to even speak. I have donated blood in decades and never had an adverse event.

Bad chills and started shaking for 10 minutes along with a fever 101 and very tired with headache. I'm still tired on day 2.

Felt like I had it again, was in bed pretty much for 30 HOURS headache, extreme fatigue, soreness and neausea.

was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: Tired feeling, eyes burning, flushed feeling. Assessment : Time of assessment 0912. Actions taken: BP 162/79, P 82, 97% O2 saturation. He was placed in a wheelchair and taken out to the triage area by RC-EMS. Blood sugar 122. 12 Lead EKG done, patient monitored additional 15 minutes and reported feeling better. Last BP 165/82, P 83. He was able to get off the stretcher and ambulate to the door to go home with his wife. Instructed to call 911 if symptoms reappear, she verbalized understanding.

1. Fever ~101 for 48 hours, dropping to 99.5 next 24 hours 2. Very achy muscles for ~48 hours, slight to moderate achy next 24 hours. 3. Very fatigued 36 hours, gradual improvement for next 32 hours. 4. Painful skin on both arms and hands for ~36 hours. 5. Swollen lower right leg and ankle for 24 hours. 6. Water retention for 12 hours. Treated self with Tylenol initial 12 hours then Advil afterwards.

Moderna COVID-19 Vaccine EUA The day of the shot I started having difficulty breathing and fatigued. As time went on, it got worse and I had to go to hospital on 03/25.

Couldn't lift vaccination arm past shoulder. Low grade fever - 14 hours later, took one Ibuprofen Extreme tiredness Slight headache All symptoms lasted about 1 day

Patient is complaining of profound fatigue for the past five (5) days since his vaccination, He states that he has been unable to leave his bed since he got is shot. Also reports , left arm pain (vaccination site). stiffness. Today he is ambulating with a walker (typically uses a cane).

1- On Day one few ours after the 2nd shot, I had my heart flutter and lost by breath few times, next day was gone. 2- Knee joint pain and tendons pain still ongoing was very hard to walk. Improving very slowly. 3-Felt like I had the flue the next day with a headache, flue like symptoms gone within 2 days, however I am on week 3 with a non stop headache. I usually never have a headaches, and now I have it every day and night since the 2nd shot.

fever of 101.8, aches from tips of right fingers to tips of left fingers and down my back to my buttocks, headache, blurry vision,extreme fatigue. all lasted about 28hours. now just pain at the injection site.

Opposite arm pain. Then chills and pain in all joints and muscles. It lasted all night following injection. The next few days I felt tired and easily out of breath.

1st vaccination on March, 4, 2021 - Right arm, soreness at injection site for 2-3 days. No swelling. After that I was fine. 2nd vaccination on April 1, 2021 - Right arm, Slight bodily flushing within 15 minutes of injection. About 4:00 PM started to develop mild aches and chills.. As the day progressed, aches and chills became substantial with a 2:00 AM temperature of around 102 degrees F headache and mild nausea. now 5:00 PM the following day ,i.e., now, with a temperature of 100.5. F. Injection site slightly diminished in pain. No swelling. Monitoring my condition.

Same as Dose 1. Chills, then fever started on Monday evening. Chills, fever, body aches and pains, and slight headache worst on Tuesday with fever high of 100.9 F. Continued Wednesday and finally felt ok Wednesday night. Almost identical side effects as Dose 1.

Low fever, chills, fatigue, muscle soreness, vomiting, severe headache Started at 10:00 pm at night and ended at 4:00 am. The headache continued into the next day and lasted a total of 12 hours.

Severe body, neck and joint pain. Stomach cramps, headache, fever reach 101.8, vertigo, face and lips felt numb, absolute exhaustion. These symptoms lasted for 48 hours although the worst of it was the first 24. Many of the same symptoms we the same I had with Covid in November -December 2020. I did not, however experience sore throat or congestion.

Severe bloodshot left eye -- I do have a picture if helpful to you Minor nasal congestion Slight headache 1 day prior to the bloodshot eye - relieved by Tylenol

Approximately 12 hours after the injection I began to suffer headaches muscle aches and a fever of 101.7. Continued throughout the night into the next morning.

He has been sleeping all day and at 1:30 pm he has started throwing up and has a fever of 100.9. This is less than 24 hours after receiving his first dose of his vaccine.

General covid symptoms. Very tired, loss of appetite, muscular aches especially hip area, inflammation at injection site, mild nausea

On 01-24-2021, I went into the hospital because I had fever and chills. I also experienced soreness in my left arm with body aches in my joints. Lab work was performed at the hospital. I stayed at the hospital 7 days.

Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy. On 06-Apr-2021, the patient received first dose (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown. Treatment was not reported/ unknown. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

Purpuric rash; Accelerated hypertension; Systolic congestive heart failure exacerbation; nausea; Generalized non-itchy, non-painful rash a day after receiving the vaccine; Thrombocytopenia; few loose stools; Fever; Chills; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) and NAUSEA (nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Purpuric Rash and Thrombocytopenia After the mRNA-1273 (Moderna) COVID-19 Vaccine. Cureus. 2021;13:4 Previously administered products included for Viral hepatitis C: Interferon. Concurrent medical conditions included Viral hepatitis C, Chronic kidney disease (Stage 4, with a baseline creatinine of 3 mg/dl.), Uncontrolled hypertension, Systolic heart failure (Ejection fraction of 35%.) and Liver cirrhosis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine) (seriousness criterion hospitalization), THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization prolonged and medically significant), PURPURA (Purpuric rash) (seriousness criterion hospitalization), ACCELERATED HYPERTENSION (Accelerated hypertension) (seriousness criterion hospitalization), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized for 3 days due to ACCELERATED HYPERTENSION, ACUTE LEFT VENTRICULAR FAILURE, NAUSEA, PURPURA, RASH and THROMBOCYTOPENIA. At the time of the report, RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. In March 2021, Alanine aminotransferase: 90 (abnormal) 90 U/L. In March 2021, Aspartate aminotransferase: 196 (abnormal) 196 U/L. In March 2021, Bilirubin conjugated: 5 (abnormal) 05 mg/dl. In March 2021, Blood albumin: 1.9 (abnormal) 1.9 gm/dl. In March 2021, Blood alkaline phosphatase: 216 (abnormal) 216 U/L. In March 2021, Blood creatinine: 3.2 (Inconclusive) 3.2 mg/dl. In March 2021, Blood lactate dehydrogenase (122-222): 381 (High) high. In March 2021, Chest X-ray: abnormal (abnormal) Findings consistent with pulmonary edema.. In March 2021, Glomerular filtration rate: 19 (Low) eGFR - 19. In March 2021, International normalised ratio: 1.13 (Inconclusive) INR - 1.13. In March 2021, Platelet count: 84000 (Low) 84000/uL. In March 2021, Serum ferritin (24-336): 2400 (High) 2400 mg/ml. In March 2021, Ultrasound liver: abnormal (abnormal) Ultrasound of the liver confirmed liver cirrhosis.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered THROMBOCYTOPENIA (Thrombocytopenia) and PURPURA (Purpuric rash) to be possibly related. No further causality assessments were provided for RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). Concomitant medications were not provided. Hepatitis panel showed a heavy viral load of more than 11 (no reference range was provided). Per reporter, on presentation to the emergency room the patient was afebrile, had a blood pressure 183/106 mmHg, pulse rate of 82 per minute and oxygen saturation of 96% on room air. Treatment included anti-hypertensives and intravenous diuretics. On day 3 of hospitalization, patient left the hospital against medical advice. Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.; Sender's Comments: Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.

stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMLODIPINE for an unknown indication. The patient's past medical history included No adverse event (No medical history reported. ). On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Clinic visit 4/7/21: "60 y.o. year-old male who presents for left calf pain, swelling, and bruising that began on 03/27/2021. Patient states that 2 days prior to symptom onset he received the Moderna COVID-19 vaccine. He did have symptoms of fever 102 F for approximately 24 hours. After the resolution of his fever he notice swelling of the leg with tenderness any line of bruising going down the medial aspect of his leg. He noticed more prominence of varicose veins of the left leg and began using a compression stocking. His varicose veins seem to worsen with sitting as well as tenderness, and improves with walking. He notes a tenderness over the upper calf. He denies any history of DVT/PE. He notes that two brothers sustained blood clots, one he believes was in varicose veins which were ultimately stripped and the other he is not sure of the exact nature of the clots. He is unaware of any hereditary clotting disorder in his family. He denies any shortness of breath, difficulties breathing, or chest pains." He was sent home with aspirin 325mg daily. Hospital admission 4/11/21 " 60 year old male with no PMH comes in c/o LLE pain that originally started 2 weeks ago and intermittently getting worse. The pain started around the left calf and has moved its way up to his thigh/groin area. The pain is sharp, 7/10, worse when standing, slight improvement with aspirin. Pt denies tingling, numbness, CP, shob, N/V/D, blurry vision or weakness. Associated symptoms include erythematic rash around left inner thigh, tender to touch, and swelling of calf/thigh. He works with heavy machinery but is always sitting down 1-2 hours at a time. He does have family history of DVT/PE. He is not on any daily NSAIDs or other anticoagulation and denies smoking." he was started on a heparin drip then transitioned to Eliquis and discharged the next day.

In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.

Patient presented to hospital on 4/9 with worsening dyspnea on exertion and fatigue and brown colored urine. Patient was diagnosed by hematology service with warm autoimmune hemolytic anemia (Evan's disease). It was refractory to high dose steroids, rituximab, cyclophosphamide and required splenectomy. He has required multiple blood transfusions.

I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.

5/6/2021-symptomatic with Covid symptoms of fever, cough. 5/10/2021-admitted to Hospital for Covid 19 issues.

Fever, Chills, Nausea, body pains. all started 12 hours after the shot. Got better and went away the next day.

Previous Covid + physician with documented antibodies Symptoms started 17 hours post vaccine Fever x 36 hours Chills Rigors Malaise Myalgia Mild diarrhea, anorexia,

Chills, body aches, headache, BP increased, pulse increased, lightheadedness, sweats the day after the vaccine. (The evening and the whole night.)

The patient received his vaccine on Thursday, 12/31/20 between 2:00pm and 2:30pm. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day the patient fell in his room and when vitals were collected, he had a temperature of 102 F. Since the patient was febrile, him and his roommate were given rapid COVID tests, both of which were negative. The patient's PCR test has not come back yet. Per nursing report, the patient did not experience fever again over the weekend, it was a 1x occurrence. His temperature returned to normal on Saturday 1/2/21 and remained normal through Monday, 1/4/21. Besides fever, the patient did not complain of any other ADRs.

High Fever, Chills, Weakness, Pains (joint & Muscle), Cough, Note; this was worse then when I originally had COVID in April 2020.

Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101

Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour

Patient reports low back pain fever and anxiety began 2300 on the day of vaccination. He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain. The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021. Patient was treated to diphenhydramine and symptoms resolved

Approximately 18 hrs after vaccination, pt woke up with injection site soreness, Tmax 104, dizziness, myalgias, athralgias.

Headache, Diarrhea, chills Narrative: headache, tenderness on the left side of neck, mild chills, diarrhea

Softball size soft bursa like sac developed on the evening of the injection. Following morning joint pain was in left shoulder and elbow. Fatigue was significant 1 and 2 days post vaccine. Rest, massage and warm compress was applied and swelling is decreasing at this time.

Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Tylenol, sleep till 3:30 PM, went back to sleep at 6Pm and woke up 6am.

Ache began in neck/shoulders after chills. This happened around lunch 1/7/21. Took acetomenphin . Chills and aches continued until into the night. Took Temperature around 2:30 am 1/8/21 and it registered 99.8. Took more acetomenphin and sweated it off. Aches and chills continue today, 1/8/21 into lunchtime. Taking acetomenphin approximately every 4-6 hours.

Headache, Myalgia, Arthralgia, Fever, chills, fatigue, diarrhea Narrative: Employee received vaccine on 01/04/2021 and did not experience symptoms until the following day. On 01/05/2021, employee began experiencing fever (100 F), chills, headache, joint and muscle aches, fatigue, and diarrhea. Of note, employee reports attended a football game on 12/26/2020. Reports using Dayquil and Nyquil currently for symptoms. Symptoms have not yet resolved.

headache ringing in ears and light sensitivity and one week later redness swelling and itching at injection site.

Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open. Also some nasal drainage and feeling of unwell. Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out. Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here.

Flu-like symptoms within 18 hrs of vaccination. Moderate/Severe body aches, fever, chills. Lasted for about 36 hrs after onset.

Reports feeling of chills, debilitating headache, muscle aches. No fever. Tylenol does not help. Unable to get out of bed.

I was fine the day of the vaccine. When I woke up the next day I felt like I had a severe case of the Flu. I had severe body aches, headache, muscle weakness, worse cough, injection site pain and swelling, chills, weakness/tiredness, I felt like I had been hit by a car. I just tried to sleep and drink Gator Aid. The second day out from vaccination I felt much better. Just slight headache, body aches, weakness. My injection site started to hurt later in the second day. It still hurts today-seven days out from administration.

No problems on vaccination day. I woke up the next day with severe flu-like symptoms. I had a severe headache, severe body aches, cough, injection site pain, weakness, extreme tiredness, The flu like symptoms lasted one day and were gone by the evening of the second day out from vaccination. One week later I still have muscle pain at the injection site.

feverish, chills, shaking, 99.9 fever, extremely nauseous, Zofran did not work, nausea went away that night, fatigue, red square size of a stamp at injection site, size has increased in size, Dr rx Bactrim antibiotic

about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )

10 days after receiving vaccine I experience spread hives and throat itchiness. Went to ED. Took Prednisone for the next 7 days with hydroxixyne which totally alleviated all symptoms. Also I went to my Primary Care MD for f/u. After treatment hives started again, then I started to take benadryl orally which kept my symptoms in check but today it came back worse again despite medication.

heavy sweating, then passed out twice ,hitting the floor 5 hours after getting shot . went to summa ed the next day , cat scan,bloodwork and ekg came back ok. on jan 16th i went to a dentist for a abscessed tooth.after i passed out i had a headache for 2 days and felt out of sorts.

Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. Fever 102.9. Severe headache. Vomiting next morning. Bedridden 36 hours total.

At about 1am the night following receiving the vaccine, I started getting a headache and indigestion. At about 1:30 I had diarrhea for the next 3 hours until I took an anti-diarrheal medication. My wife and I ate the same food that day. She did not get sick. I haven't had diarrhea in years. I had a lingering headache the following day.

Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F

Freezing to death, chills, sweating. hurting everywhere so bad, and really bad headache, nausea, chest pain, lowered his blood pressure, sore muscles, extreme tiredness, ambulance picked him up and was in the ER all day giving him fluids, took about 2-3 days before he started feeling better. The whites of his eyes are still red.

Beginning on Day 2, nausea on and off sustained now through day 25 Today). Loss of appetite as a result. Extreme muscle pain on day 10 (just day 10). Extreme Fatigue now through day 25, with headache. Dizziness and head pain beginning week 3 after shot. Unable to function properly. Symptoms are not constant, come and go from mild to extreme.

After 12 + hours I felt a headache (like a sinus headache), In addition I experienced fatigue, light headedness, and mild sense of nausea. It felt like I had Covid again, but to a lesser degree.

Within 8 hours of the vaccine I was experiencing a right sided headache, sharp shooting; aches; fatigue and mucousy diarrhea. The right sided headache continued for days. On Saturday evening Jan 16th it became the worst headache of my life. Like a fool I didn't go to ER until Monday morning when I developed left handed weakness. I was visiting my son and presented to the Medical Center ER where I was diagnosed with an acute sub-dural brain bleed and airlifted to Specialized Hospital. Was admitted to the Neuro-Neurosurgery Unit.

lightheadedness, headache, aches in the legs post-vaccination which improved with rest food and hydration

approximately 24 hours after the injection, I had no fever, but chills, sweats and overall since of fatigue. My resting heart rate was at 100 for a few hours. Normally, it's around 76. I noticed on deep breaths, I felt the need to cough (no phlegm, just a dry cough. One or two coughs per attempt). No medical care sought. Those symptoms dissipated and I felt good. Then on January 20 and 21, the chills returned. They lasted about 8-10 hours, then they were gone. I also developed a headache during the 20 and 21 episodes. I checked yes in the below adverse recovery box, but I am uncertain as to what tonight and the rest of the days have in store.

The patient was scheduled to receive her 2nd dose of the series on 1/27/21 and received it on 1/19/21. The patient reports experiencing a headache, chills, fatigue, and a high temperature of 100.1 within 6 hours of receiving the vaccination. The symptoms were intermittent and resolved within 24 hours of receiving the vaccination.

Headache, head feeling very heavy and nausea; So far lasting for 4 days and not getting better; I took Tylenol but does not help. Last night was the worst couldn?t sleep all night

Dizzy, lightheaded, severe headache, shaking, freezing cold, profuse sweating, muscle aches, joint pain, tachycardia, minor chest pain, nausea, dehydration with constant thirst, metallic taste in mouth. Took 2 tylenol pm pills, drank water and 7-up. Symptoms were gone 20 hours later except for very sore right arm, neck and back muscles which were completely gone and normal by day 3.

Slight headache for 3-4 days, overall muscle and joint fatigue for one day, loss of appetite from 20-36 hours after injection

Severe body aches. Fever up to 102F. Chills. Taking analgesics and antipyretics for symptom relief.

NIGHT AFTER VACCINATION : WOKE UP WITH CHILLS AND HOT SWEATS DAY AFTER: SEVERE FATGIUE , EYES WERE RED

At first I was fine, later that night my arm was hurting, then the next thing I know everything was hurting in my body. I had to take off work Tuesday and Wednesday. I think I also had a little fever. Today I am feeling better, the arm is just a little sore.

Received vaccine at 2:30 PM. By 8:30 PM was beginning to develop these side effects which lasted around 24 hours: Headache, body aches (joint, muscles), generally tired and hard to focus. By second morning after vaccine, was back to normal. No treatment required.

Patient reported experiencing pain, redness and swelling at injection site, mild fever, headache, fatigue. Symptoms onset about 6 hours after second dose of Moderna COVID-19 vaccine. Symptoms resolved within 24 hours of onset.

The patient received his vaccine on Monday 2/1/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 99.1 F. Since the patient was febrile, he was given rapid COVID tests, which was negative. Patient was not in distress.

Pain right arm- site of injection- not able to move for almost 3 days, followed by chills, body ache, and headache. Symptoms lasted for 3 days.

Moderna COVID?19 Vaccine EUA Extreme fatigue, visual hallucinations, anorexia. Symptoms worse at ~12 hours, significantly improved by 72 hours but not resolved.

injection site pain and tenderness. fatigue , headache, muscle pain , joint pain , chills, fast heartbeat.

Fever, chills, nausea, vomiting, severe headache, severe muscle pain, joint pain, muscle weakness, extreme fatigue

Rapid heartbeat that lingered for a couple of days. Cold symptoms (runny nose) started 4 days later (may be unrelated)

Occurring in late evening of 2/8/21 and all day 2/9/21: Muscular aches/soreness/stiffness (no intense pain)...primarily lower back, lower sides (kidney area), upper back, neck. Left upper arm "pain" at injection site. Slight fatigue. Very slight headache (not serious). Fingers of both hands ache (not sure if arthritis flareup). NO fever.

Moderna COVID-19 Vaccine EUA - 2nd shot - Pain in L Arm at injection siterna COVID-19 Vaccine EUA - General weakness, flu-like symptoms

Moderna COVID-19 Vaccine EUA Body aches, tiredness, headache, muscle pain, chills, coughing, injection site pain, exhaustion.

Onset 14 hours. Then about 5 hours of intense total body muscle pain. Then went away and was just fatigue. No recorded fever.

headache radiating to teeth with eyes bulging and blurred vision. muscle aches radiating from shoulder down to the back. Aferbile with chills

starting 18 hours after shot, chills, fever, muscular shaking, weakness in legs and jpoint pain specifically in the hips. Lasted 12 hours and then went away

fever 101; max, lasted for about 24 hours; fatigue 24 hours; headache 36 hours; sensitivity at injection site 36 hours

Injected 2/8 began getting headache afternoon of the 10th, developed sever night chills by 1130p the night of the 10th, along with fever of 102 degrees, body aches and pain. Low O2 saturation at 92%. Though possibly unrelated I developed cellulitis at incision on left knee which is now being treated with antibiotics. Was directed to and seen by Urgent Care facility.

Recieved 2 doses of covid vaccine - 1/6/21 and 2/2/21. Went to ICC reporting: scratchy throat productive cough (yellow mucous), and congestion six days after 2nd dose of vaccine. Negative COVID PCR on 2/21/21. Diagnosed with Viral URI with cough.

Approximately 11 hours after the injection: SEVERE body aches - every joint in my body felt like I was being crushed Fever of 102 degree at about 2:00am - Chills; Headache; Fatigue - very "heavy" feeling like I couldn't stay awake if I wanted to; Recovered to about 90% at almost exactly 24 hours, still a little headache and some joint "tenderness" today, but mostly gone.

Tender two nights after vaccine admin that self resolved. 21 days after, the arm started throbbing and having deltoid spasms. Pain radiated from elbow to skull up To ears. Spasm would come and go. Tingling in forearm also reported. Lasted three or four days and then went away the day before the second shot.

After Covid vaccination #1, patient was instructed to be monitored for 30 minutes due to history of sulfa allergy. After about 5 minutes of observation, she approached me (pharmacist) saying she had tingling and a little numbness in right side of lower face. She reported no difficulty breathing and no other symptoms. I consulted the two other pharmacists I was with and we decided to not take any immediate action but continue monitoring. I checked in with patient every few minutes to ask if symptoms were getting better/worse. For first 30 minutes, pt said symptoms were the same. After about 30 minutes, she said she had a little itching down her throat, but still no difficulty breathing. We gave her 50 mg diphenhydramine and monitored for 30 more minutes. After 1 full hour of observation, she never reported difficulty breathing. She did get tired from the Benadryl and was up on moving around and said feeling slightly better. After 1 hour, she went back to her room.

large red bright red bumps on forehead and top of skull that is painful/irritation to touch, off and on nausea , intermittent headache

Approximately 24 hours post injection-fever-102.4, and fatigue. Fever persisted for 24 hours then resolved. Fatigue persisted for 48 hours then resolved. Possible side effect-72 hours post injection-queasy stomach, malaise-Duration-approx. 6 hours all resolved. Also, cold sores erupted on lower lip for no reason. Being treated with Abreva.

Nasty headache which remained after acetaminohen/ibuprofen, congestion, fever, felt like my hesd was on someone else's body, aloofness, etc.

Starting around 5 pm on day of vaccine I started getting a low grade fever and it continued through the next 24 hours. I took 2 500 mg Acetaminophen around 10 pm and went to bed. During the night I had some cold sweats and did not sleep well. The next day, I had chills and some body aches. I too 2 500 mg acetaminophen two more times during the day. I was fatigued with some body aches throughout the day. The next day was very similar to the 2nd day after the shot but no fever. It is now the 4th day after the shot and I feel back to normal.

On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sleep, headache, profuse sweating lasting until 2/3/21. Still experiencing lingering arm pain at injection site.

2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.

19 hours after the injection there was fever, rigors, sweats, headache, nausea, myalgias. This lasted for approximately 30 hours then resolved. Tylenol 1000 mg q 6H and

Muscle and joint pain Exhaustion Fever (101) Chills All began by 4 hours post injection and resolved by morning of 2nd day post injection

Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.

Moderna COVID-19 - Symptoms included: headache, muscle pain, joint pain, chills, nausea, low grade fever 0f 100.0 F, and fatigue

Fever, extreme aches, shallow breathing, dark urine, fatigue, joint pain. Patient had had Covid three months prior (mid-November). Vaccine side effects were the same as when he had Covid and lasted 36 hours.

Fatigue, nausea, fever 102. This was my first shot. I was given two shots because the first one didn't have the needle on all of the way and a lot ran down my arm. They decided to give a second one.

First vaccine received on Sat 1/23. On Tues 1/26 began to experience body aches, chills, headache. Spoke to triage nurse on Wed 1/27 who thought were symptoms of vaccine. On Wed 1/27 continued with body aches, extreme chills, headache and developed a 101 fever. On Fri 1/29, went urgent care who continued to attribute the symptoms to the vaccine. On Sun day 1/31, went urgent care again experiencing the same symptoms along wot a 104 fever. Sent to ER and admitted to the hospital. Hospital stay from Sun 1/31 to discharge on Fri 2/5. Admitted to the hospital with pneumonia attributed to my immune system going after the vaccine allowing for the the development of pneumonia.

Heart rate became elevated from 7pm to 12:30am. Averaging around 100bpm. Had the chills during this time period with temperatures of 95.5 and 97. I feel asleep and woke up around 3:30am and deltas if I broke through.

Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to lay down, stay home from work. Rested. Took Tylenol and slept throughout the day. Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature up. Jogged for 60 minutes, returned, ate and rested again. 4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level. 5th day back to normal.

Patient was unable to get out of bed the whole day and missed all three meals. Patient had a fever of 100.6 and had generalized weakness and malaise. Patient was also confused. Patient was experiencing tachypnea and shallow breathing.

Gave moderna vaccine at 3:23pm in right deltoid. During observation period, patient was experiencing tingling in both of his hands. Due to past history of allergic reactions, gave him diphenhydramine at 3:42pm. He felt okay for a short period of time and then started to have tightness in his chest. He could still breathe fine, but called 911 due to past anaphylactic reactions. While on the phone with 911 he stated feeling more tightness in his and then decided to give epi-pen shot in left upper left thigh at 4:02pm. The EMT showed up immediately after and took patients vitals. EMT advised if wanted follow up monitoring could take him to ER. Patient wanted to go to ER for further monitoring. We followed up with patient's wife and she said he was still not feeling very good and had follow up appointments with his cardiologist. He also came in the store on 2-26-21 and all his test were normal, but still was not feeling like himself.

abdominal pain diarrhea with constipation painful bowel movement chills muscle aches and headaches fatigue

Ok I got my 2nd shot on Tuesday (03/02/2021) about 2:30 p.m. and was feeling great all evening. I woke up at 2:30 a.m. and thought I'd been hit by a truck, my whole body was aching like nothing I've ever experienced. I also got chills and was shaking I thought I was on one of those machines that shake paint cans. I also had (and still do) a headache. The body aches subsided about 10:00 p.m. (03/03/2021). It is now about 5:00 p.m. on Thursday 03/04/2021 and I still have a slight headache and I am fatigued but starting to get some energy. On my left arm where I got my shot it is very warm, red, and about the size of a goose egg in the area I got the shot.

About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But about Friday, my right hand began to ache a bit. It became excruciating by Sunday. My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints. The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.

started around 9am on 03/05/2021 with lower back muscle pain which I found odd, as the day has progressed a headache started and has kept on increasing on intensity, around 2pm I got sleepy and slept for about 30 minutes, the headache continue but now muscle pain discomfort is now down my knees and I started feeling body aches, I drove to pick up my child from school at 4pm and noticed confusion and irritability, once I got home took my temp and was 97.9 a few minutes later 98.2 now is 98.4, I called vaers at 8008227967 and the woman was not helpful at all in fact she was annoyed by the call, once I insist she hear what I have to say then she sounded nervous and wanted to get a statement but I decided to call moderna instead at 8666633762 and they listened and took my statement and said that more likely I will get a phone call, the side effects got so intense that I forgot I had a follow appointment with my primary care for a physical. I called them and they had me marked down for no show but once I explained they set up another follow up appointment.

Significant aches and pains all over my body, tired, loss of appetite, mild nausea. No fever. No respiratory problems. Subsided in about 36 hours. Back to normal in about 48 hours.

Headache, grogginess, jittery, shivering, soreness at point of shot, tiredness, feel like a truck ran over me, extremely lethargic. now it's the second day. Feeling cold stopped, a little better.

Pain, tenderness, and swelling at injection site for two days. Plus joint pain, chills, fever fatigue for three days.

Moderna COVID-19 Vaccine EUA 100.4 degree fever, chills, sweats, severe joint pain in thumbs, swelling in left testicle, headache, gained 12 pounds of water weight over two days. Swollen legs with painful rash from knees down. Continuing joint pain in hips, knees, ankles

Chills, body aches, fever 36 hours. Rash started two days after vaccine and lasted approximately 12 hours

Upset stomach, severe chills, body aches lasting about 8 hours. Then, fatigue lasting through the following day.

My injection site was sore. I had chills the night after I received the vaccine and bodyaches the next day.

fever, chills, head ache, light headed, sweats, body hurt. for about 12 hrs. just tired now the second day, a lot better! it was just like it was when i had Covid 19.

Extreme chills and fever. Cold sweats. Shaking. I took 1 Aleve and went to bed at 8pm. Had chills throughout the night. Woke up the next morning feeling much better.

1. Shaking chills, fever and flu symptoms for one day followed by a day with malaise. 2. Daily diarrhea, watery stool, cramping and bleeding lasting one month. Currently slowly resolving. Treated with a variety of remedies over the month, individually and in combination. ( Pepto bismol, charcoal capsules, imodium, rice, tumeric, and Xifaxin) Imodium would stop the cramping but not the wateriness of the stool. Unlike any diarrhea over the course of my life. I will not be taking any booster shots.

A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing. Was transported to Medical Center for further evaluation.

After first shot in series, I developed slight headache, minor weakness, minor shoulder pain. After second shot in series, 8 hours post-injection, I developed headache, moderate to severe joint pain throughout, fever around 100, extreme fatigue and weakness, slight difficulty breathing. Went to bed for 19 hours and began to feel better with recovery in two days. 14 days post-injection, I developed a systemic rash throughout my body. Consulted with my PC physician. Was prescribed Medrol Dose Pack. This had very minor effect on rash. Returned to physician for consult upon completion of steroid series. I then received a steroid shot intramuscular in right hip and one week oral steroid protocol. This achieved a more positive result, almost clearing up the rash. I had a consult with a dermatologist on 03/02/2021 who confirmed the opinion that the rash was probably a side effect of the Moderna vaccine. The rash has returned fully as of 3/14/2021.

I had Covid in December, 2020. Test result positive on 12/16, tested 12/15. Symptom's then were- chills, complete body sweats (soaking), fever (spiked to 102F, but would subside quickly), intense body aches and pain, lost taste and smell. All symptom's lasted for apprx 3 weeks, except sense and smell, that took 3 + additional weeks to return to almost pre-covid. I drank pedialyte and cranberry juice, took EmergenC, a daily Multi as well as extra vitamins C and D everyday. For pain a took 6-800 mg of Ibuprofen as needed. Did not lose my appetite.

PT REPORTED AFTER RECEIVING VACCINE HE WAS A LITTLE FATIGUE & ONCE HE GOT HOME HE REPORT SEIZURE ACTIVITY. HE STATED FOR APPROXIMATELY 40 MINUTES "HE WAS JUST IN A DAZE & STARING" AND AFTERWARDS HE WAS FINE.

For about 48 hours I felt out of it--lethargic, chilled, lack of appetite, slight headache, drainage down back of throat. Last symptom still exists.

Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vaccine. Each time the patient received the vaccine, he presented to the emergency department the following day with the following signs and symptoms: AMS, tachycardia, fever (Tmax 104.5), lactic acid 3.8, CRP 1.65, CPK 298, Troponin T 0.107, WBC WNL.

Patient had 2 waves of cold sweats during his 15 minutes waiting period. Patient also felt palpitation or racing heartbeat. Throat became scratchy. Globus sensation. Denied swelling of the throat.

The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:00 AM with significant discomfort in my chest. My chest felt heavy and when I inhaled it felt like someone was squeezing both lobes of my lungs. I got out of bed and went to the bathroom to urinate. I went back to bed and tried to get back to sleep. The discomfort in my chest continued and seemed to get worse. I got back out of bed at about 2:45 AM and went downstairs where I walked around my living room to see if that would help me feel better. I continued to feel severe discomfort in my chest and lungs. I did not otherwise feel bad. I was not congested. I could still take a deep breath but it hurt to do so. I took my temperature and I did not have a fever. At about 3:00 AM I woke up my wife and she drove me to the emergency room at Medical Center. On the car ride to the hospital I started to feel much better. By the time I checked into the emergency room most of my discomfort had dissipated and only a very slight feeling of heaviness remained in my chest.

Got shot on the 14th of March about 2:00 am that night got aches, pains , cold chills and head ache. These all lasted until around 10:00 pm the 15 of March.

Received vaccine, and no reactions. Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye. General soreness around his mouth when he tries to eat or talk a lot. Limited movement of his face do to swelling, difficulty closing his eye, and headache. Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21. Was given corticosteroids for 9 days Prednisone 60 mg. The symptoms are slowly improving but still has the Bell's palsy.

fainting, sweating, eyes rolled back, slouched over in chair then perked back up. still complained of dizziness and sweating. called 911 within 1 min of episode and paramedics came to take over. Patient was talking and coherent but sweaty.

Maderna Covid Vaccine 2nd dose Extreme chills that night, got up to go the bathroom,, had sweats and suddenly felt very dizzy and fainted on the bathroom floor. Felt very weak and couldn't get off the floor. Had a fever of 101.6, Wife had to help me get up after some time on the floor.

Exactly 32 hours after injection, both myself and a 41 year old friend who got the vaccine with me experienced the following: vomiting, incredible amounts of mucus coming from lungs, uncontrollable diarrhea, violent sweating and chills, extreme headache, bed-ridden for two days. Both the pharmacy and the health dept. refused to record our reactions, and the health dept. hung up when we tried to report this incident. The pharmacy would not call us back.

Normal side effects of fatique, aches but have been getting worse and worse chest congestion and wet coughing. Chest hurts.

flu like symptoms body ache fatigue mild fever felt like my nerve endings on my arm were sensitive ,,chills.....its been 48 hours seems to have gotten better just a little worn out

Slight headache and vertigo when getting up after sleeping. Able to walk but have to be careful. Lasts for 15-20 minutes unless I drink coffee -- then it goes away after about 5-10 minutes, with headache last to go. With vertigo: Blood pressure normal. Heart rate normal. Blood O2 normal. Temperature normal. Had a constant three day case of vertigo back in 2003 after flu-like illness. This is much less severe, but now on 11th day.

Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache. These symptoms lasted all day and into the night with some minor relief. Following morning woke up to light-headed, headache, and some dizziness. Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around. Still feeling light-headed. The following days experience ligh headedness in the morning and serious dizziness when laying down for the night. After about an hour of getting up, feel almost normal but not fully.

Started to have chills around 7:00pm Friday night, then around 4:00am Saturday morning, I got up to use the bathroom and pasted out in the bathroom. My wife sad she heard a loud noise and came into the bathroom to see what had happened. She called my daughter and son-in law to come over and get me up I couldn't move at the time, I must have hit my back and neck because they are sore. Then Saturday night I had sweats all night, today I fell a little better except for my back and neck, I have a doctor's app. Friday. I am concerned about the 2nd shot if the 1st shot did this to me.

started having intermittent headache on 03/08/2021 which he describes as dull pressure starting in his frontal sinuses and working the way posteriorly on both sides. They are intermittently present and range from 2?5/10 in severity. No associated photophobia. He has been taking Tylenol at home which provides moderate amount of relief. He saw a provider on 3/15 and was prescribed high-dose Augmentin at that time which he has been taking without improvement. He endorses subjective fevers and chills but his body temperature was 99 F. Mouth ulcers started a few days ago. With that, it became very difficult for him to eat or drink due to excessive pain. He became concerned because he was also on immunosuppression for transplant and ended up coming to the ER for further evaluation where he was admitted. Of note, he was switched from Tacrolimus to Sirolimus 3 days prior to his vaccine 3/20 while inpatient, developed fever of 101. Blood cultures negative. Around time of drug changes and vaccine, patient also had a tooth repair.

Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.

I had Covid in November and was told that there was a high probability that I would get sick but was not prepared for this. It is like I am sick all over. Fever, no taste (It all reminds me of cardboard), exhausted, sleeping, no appetite, mild nausea, headache, winded easily

Developed bad, itchy hive-like rash all over trunk of body front and back within 6-7 hours of injection. Treated with 25mg Benadryl for very little relief. By four days post vaccine it has spread to groin and head. Mild nausea and fatigue

Extreme fatigue on first day. On the second day I experienced dizziness and vertigo. I have not felt safe to drive although the symptoms are becoming less severe the last 24 hours.

Severe headache, 97.1 temp with extremely hot skin, rapid heartbeat (120 bpm). Next day felt fine with elevated heart rate. Monday, 3/22, all normal, including normal 60 bpm heart rate

Severely sore should/arm. Extreme fatigue and hot sweats at second day. No side effects at day two of vaccination.

pt states that he developed a headache, sore arm, had fatigue along with body aches and pains. He was dizzy and eyes were very droopy. He woke up next day and his arm is very sore, he is very tired and has a flushed face. Pt feels like his symptoms are improving now.

do not know the lot number but this is what is on my woke up at about 3am 3/23/2021 with a horrific headache and way sick to my stomach and then severe low back pain in the afternoon of 3/23/2021; as I write this now my headache is not as severe, stomach is meh at best and low back is still very sore.

Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometimes a feeling of shortness of breath

1:25pm: HA and diaphortic BP 176/88 P 94, reports HA d/t flourescent lights, feels "better" 1:45pm, Repeat BP 162/78 P 89 Glucose 137, ambulated to exit with staff

Abscess on the liver; missed his second dose; Fever; A spontaneous report was received from a consumer (patient's wife), regarding a 61 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced abscess on the liver (liver abscess), fever (pyrexia) and inappropriate schedule of product administration. The patient's medical history was not reported. Concomitant medications was not reported. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient developed fever and was hospitalized because of abscess on the liver. The patient was hospitalized for eight days and missed his second dose because doctors said that the patient was still weak to take the second vaccine dose. The patient was discharged on 27 Feb 2021. Treatment for the events included unspecified antibiotics. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, abscess on the liver, and fever, were considered as unknown. The event, inappropriate schedule of product administration, was considered recovered/resolved.; Reporter's Comments: Although a temporal association exist, and there is lack of patient's medical history and list of concomitant medications, based on the known risk and etiology of liver abscess, the events are assessed as unlikely related to mRNA-1273 administration.

Fatigue several hours after shot with soreness in arm. From 3/19 - 3/23 I experienced chills and significant body aches and feelings of sudden fatigue that required me to lay down and nap. I felt I had a fever and had a low fever of 99 on and off while taking Tylenol. I only took my temperature a couple of times. The last three days I?ve felt better and really only feel more fatigued usually and have been going to bed earlier.

Chills sweating bad headache Throwing up stayed in bed for 36 hours when I stood up very dizzy 45 hours later I am feeling a lot better

Severe soreness at injection site. Fatigue Stomach cramps Joint and muscle aches Bad headache Diarrhea High fever chills severe sweating Dizziness

Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted at least 1 hour). Eventually went away. Then two days later, Tinitus and lethargy similar to past MS symptoms, felt "off".

Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination

Memory problems, some increase in headaches. Also issues with balance and bumping into walls. Still to not have smell or taste. These symptoms have continued for 3 months after vaccine. Initially after vaccine became acutely ill with high fevers 102-104 f. Also became severely weak with severe muscle aches and severe headaches. This lasted for 7 days with worst at the beginning. Then I have had the memory loss and equilibrium and loss of ability to spell simples words that I had no issues with before. I have had these symptoms for 3 months. I thought it would all get better but it has not. I thought I better let you know these problems. I did not want to but because they have continued I thought I better tell you.

Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough. The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue. On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious. On 25 Mar 2021, he coughed up some yellow mucus. Treatment for the events reported included pacemaker and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

CHILLS, BODY ACHES, HEADACHE, STIFF NECK, LOW FEVER, UNCONTROLLED SHIVERING. SUBSIDED AFTER 24 HOURS.

Monday 3/29/2021 at 9:00 am received the second Moderna vaccine. After 5:00pm, pain started at the injection location followed by body chills. Tuesday & Wednesday 3/30-31/2021: Arm pain, body chills, and joint pains. Thursday 4/1/2021: light arm pain, on and off body chills, joint pains, and fatigue. The second shot?s symptoms were less severe than the first shot.

Chills, shaking, cold, sleeplessness - 12hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination. Experienced a continuous and higher than normal rest heart rate, up to 120 ppm, for two days straight after vaccination - this is 30 to 40 bpm above my normal rest heart rate - on day three my rest heart rate returned to normal (80-90bpm) Blood glucose levels were unexplainably higher than expected on the morning reading after the vaccination - 176 mg/dl. Normal expected result range 90 to 135 mg/dl.

Fever, chills, fatigue, headache, muscle pain, joint pain beginning at about midnight, nine hours after the vaccine administration, and continuing throughout the next day into the early evening as I complete this form at about 7:30pm, 4/3/2021.

Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.

high fever (103F) despite Tylenol. low O2 (92%), raised resting heart rate, fatigue and chest discomfort

Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Had extreme chills for approximately one half hour, then was okay until following night had a mild fever for a few hours, was fine after and since then.

Pt found unresponsive in hospital room with large amount of vomit. Patient pronounced dead shortly after with cause of death noted to be aspiration pneumonia with hypoxemia leading to cardiac arrest. Pt received vaccine 1 month prior so I wanted to report this.

Patient received the first Moderna Covid-19 vaccine and a few weeks later he noticed jaundice and hematuria. He was admitted to the Hospital, and was noted to have dramatically elevated eosinophils (26.29 k/uL), elevated creatinine (2.36 mg/dL) and elevated LFTs (AST/AST/Alk Phos/Tbili all up, mostly direct). His eosinophils improved with pulse dose steroids and the diagnostic work up continues. There is diagnostic uncertainty about what caused this dramatic increase in eosinophilia, but it appears temporally related to getting the vaccination. Our working diagnosis is autoimmune vasculitis, but he is also being treated for possible parasitic infection, and will require very close follow-up. 61M with PMHx HTN p/w generalized fatigue, L flank pain, and decreased UOP. He was in his usual state of health until 5 days prior to admission with onset of general fatigue/sluggishness. This was followed by a few days of dull abdominal pain, watery bowel movements, and increased frequency which spontaneously resolved, though the fatigue persisted. Yesterday evening, he noticed new L flank pain, red urine, and decreased UOP associated with mild dysuria (he describes it as needle-like pain in his urethra) which prompted him to call EMS. Denies fevers/chills/night sweats, myalgias, respiratory symptoms, melena/hematochezia. He's never had pyelonephritis or kidney stones before, no recent urinary instrumentation, antibiotic use, or hospital stays. He recently received the first COVID vaccine and is due for the second COVID shot on Monday. He lives with his sister and works as a mechanic. He is not on any other medications or supplements. Not currently sexually active. ED Course Vitals: Temperature: 36.7 °C (98 °F) | Heart Rate: (!) 103 | BP: (!) 169/121 | Respiratory Rate: 18 | SpO2: 96 % | | FIO2 | Weight: 104.3 kg (230 lb) Exam: L CVA TTP Labs: Cr 2.34, bicarb 18, WBC 37, UA w/ 3+ blood, +1 LE, nitrates, >182 RBCs, 32 WBC, no bacteria, no casts Imaging: CT/AP with mild L hydrouretonephrosis, b/l periureteral and perinephric stranding, b/l urothelial thickening Interventions: CTX 1g, ketorolac, 1L LR, morphine ===================== Hospital Course 4/10-4/16 ===================== #B/l Pyeloureteritis with Eosinophilia c/f Eosinophilic Pyeloureteritis #B/l L Hydroureter/Hydronephrosis, B/l Perinephric Stranding and Pericystic Stranding #Profound Eosinophilia Pt presented with malaise, hematuria, decreased UOP and markedly leukocytosis with predominant eosinophilia to 26k and was found to have L hydroureter/hydronephrosis, b/l perinephric stranding and pericystic stranding on CT A/P (4/10). Notably has been afebrile and fairly well appearing. Symptoms were preceded by several days of watery diarrhea, cough with sputum production and subjective weight loss. Recently received moderna vaccine, and he was concerned it causes his symptoms. Underwent extensive workup as below with involvement of multiple services including Renal, Pulm, Rheum, Allergy, ENT, and Cardiology. Had one nasal lesion biopsied by ENT, which was non-diagnostic. Renal bx prelim without clear e/o vaculitis, although obtained after steroids. Negative testing for primary hypereosinophilic syndrome. Extensive w/u notable for ANCA positive at 1:80 with MPO only slightly elevated (20, uln 19) and PR3 wnl. cMRI with eosinophilic cardiomyopathy, for which cards was consulted as below. Additionally, toxacara ab positive and schistosoma ab indeterminate, although per ID both schistosomiasis and toxacara infection unlikely. Per rheum, overall felt presentation 2/2 hypereosinophilic syndrome, potentially the eosinophilic stage of EGPA (given low + ANCA, low + MPO) vs. End organ effects of idiopathic eosinophilia. Briefly received CTX 2g IV qd (4/10 - 4/12) until diagnostics returned. Treated with solumedrol 1g qd x3d (4/11-4/13) transitioned to prednisone 60 mg qd (4/14-) to be continued until rheum f/u, with rapid decline in eosinophilia. Received pre-treatment with PO ivermectin 20 mg before steroids. Treated with flonase nasal spray, symbicort and albuterol for respiratory symptoms. Deferred cyclophosphamide, with consideration of IL-5 or IL-5R targeted biologics as an outpatient. Treated with atovaquone for PCP ppx. Per ID, treated with praziquantel (for schistosomiasis) and albendazole (for toxacara) out of an abundance of caution, although low c/f visceral larva migrans given lack of compatible imaging findings and no known exposure to dogs and cats or schistosomiasis given remove travel history. Data - CT A/P (4/10): Mild L hydroureteronephrosis with b/l periureteral and perinephric stranding and b/l urothelial thickening. Pericystic stranding. - 4/11 CT Chest with parasinus mucosal thickening and sclerotic 1 cm lesion likely benign lesion or bone island - 4/11 CT Face with parasinus mucosal thickening and small fluid levels and sclerotic ovoid 1 cm lesion in neck of right mandible potentially representing benign fibro osseous lesion or bone island - PFT with severe obstruction and elevated FeNO c/w eosinophilic infiltration - Heme review of smear with normal Eos - Echo TTE with LVH nl EF 52% - Vitamin B12 >2000 - Urine Eos undetectable after steroids - SPEP with polyclonal hypergammaglobulinemia - Sinus Bx equivocal - ANA, ANCA (1:80; MPO 20, PR3 3), ESR (128), CRP (66), RF (<13), C3 (82, slightly low), C4 (10) - IgE 355 - Aspergillus IgG and IgE <19 - HIV non-reactive - RHP with CHIP mutation which will need f/u - FIP1L1 negative - Schistosoma ab equivocal - Strongy ab negative - Toxacara ab positive - Leptospira ab negative - Tryptase wnl - RHP notable for CHIP mutation as below - BCR-ABL negative - FIP1L1-PDGFRA negative - peripheral blood flow cytometry unremarkable #AKI on CKD #Nephritic syndrome #Urinary retention/hydronephrosis Cr 2.34 on admission. Baseline Cr unknown but Cr was 1.5 (OSH BI) and urine alb:Cr was elevated to 36 in 6/2018, at which time CKD was thought to be 2/2 untreated HTN. Now presented with persistent hematuria, HTN and proteinuria with UCx without e/o infection, all favoring nephritic process. Renal and urology consulted MALB/CCR 994.5. CT scan with hydronephrosis, felt to be eosinophilic pyelonephritis. Pt underwent uncomplicated renal bx 4/14 (after steroids) which showed preliminary very mild focus of interstitial nephritis with scattered eosinophils and immunofluorescence evidence suggestive of a mild immune complex-mediated disease without current activity. EM pending. He was treated with sodium bicarb 1300 mg bid. Hematuria improved but did not resolved by time of discharge. Cr on discharge 1.6, close to baseline of 1.5 in 2018. #Sclera Icterus #CBD Dilation on CT #Elevated LFT Sclera icteric and CBD dilation on RUQUS to 1.8cm with gallbladder sludge and small gallstones. MRCP with diffuse intrahepatic and extrahepatic biliary ductal dilatation to the level of ampulla, with associated ductal and gallbladder wall edema, complex material in the gallbladder lumen and CBD, and confluent periportal lymphadenopathy. No obstructing stone or discrete mass. Findings likely represent cholangitis such as eosinophilic cholangitis in light of severe eosinophilia.. No documented LFTs here, but OSH (BI) records indicate normal LFTs and viral hepatitis studies in 6/2018. Repeat Hep B non-reactive non immune, HCV non immune, HAV non-reactive. BIli remained stable and ALT and AST continued to rise after initiation of steroids. GI was consulted. RUQUS 4/15 with dopplers with persistently dilated CBD to 1.4 cm with sludge in CBD but with patent portal vein and hepatic veins. Anti smooth muscle ab positive on day of discharge; antimitochondrial ab pending. LFT uptrending at time of discharge, although patient declined to stay inpatient for further workup. LFT at discharge ALT 194, AST 114, ALP 262, TBili 6.3, DBili 5.3. ERCP to be considered as an outpatient. #HTN SBP on admission 160-180. History of HTN, not on any home anti-hypertensives. Per BI records, he was prescribed amlodipine 10/valsartan 160 in 6/2019, but pt reports self-discontinuation after ~2 doses. BP remains poorly controlled. Likely related to potential nephritic syndrome or renal infiltration by eosinophils, likely with contribution of high dose steroids. While inpatient, treated with hydralazine, labetalol, carvedilol, and amlodipine. BP regimen on discharge amlodipine 10 mg qd, carvedilol 25 mg qd. Avoiding ARBs and ACEI per Renal, although will likely need to add once AKI resolved. #Microcytic Anemia Patient with drop in Hct from 14.1 on admission to 11.4 4/14. Continues with hematuria, but denies current hematochezia. Suspect combination of blood loss and hypopoliferation given RPI 0.29, likely anemia of inflammation/acute illness given ferritin 1.010. Vitamin B12 >2000, Folate 11. Iron 151, unable to calculate TIBC. Noted to have persistently low MCV in low 70. Hemoglobin electrophoresis ordered. #Vitamin D deficiency #HyperPTH 25-OH Vitamin D 6. No e/o hypocalcemia. Phos slightly elevated on admission, but subsequently downtrending, likely iso renal dysfunction. Treated with ergocalciferol 50,000 U weekly x12 weeks #Right mandible lesion Sclerotic changes of the right mandible near the condyle noted on CT scan. Surgeon recommends outpatient follow-up, although patient declined. #Hematochezia #Hemorrhoids Patient with new bloody diarrhea 4/11. Some e/o hemorrhoids on exam. CBC stable. Treated with tucks pads, dibucaine ointment and hydrocortisone cream. #Little Medical Follow-up Pt reports that he has not seen a doctor in ~3 years.Cholesterol 124l LDL 73, HDL 10. HgbA1c 5.2. Will join Dr's panel on discharge #CHIP mutation RHP with DNMT3A mutation at low VAF. Will follow in cancer precursor clinic

Vomiting, dehydration, nausea, fever, joint inflammation, muscle weakness, inability to ambulate, pain, soreness and decreased appetite.

After my second shot after approximately 8 hours I got a severe headache perfuse sweating and vomiting, this went on continuously until Monday when I went to a family practitioner, she blew off my symptoms and sent me home where I continued to have these symptoms on and off. When on I was completely disabled. I filed a complaint they called on 4/15/2021, and told me I should go to ER, I told them I was flying the next day to see my mother who is passing away. I promised if my symptoms were still there in morning I would go to ER. I woke up feeling great and then I had a bowel movement my headache was so bad I thought I was having a stroke, I started sweating bullets and vomiting. it was so bad the only thing I can compare it to was when I had Tick fever in the early 90's. I called 911 at hospital I was in a dangerous arrhythmia throwing PAC's and going in and out of 2nd third degree heart blocks. They can not figure out why, the neurologist I saw theory is the same I had, a severe inflammatory reaction to the 2nd moderna shot. He put me on a 3 day course of prednisone which helped a lot in my recovery. I am currently on a heart monitor to see if the heart block was just temporary. I see the neurologist again in 3 weeks.

Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose. Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Developed a high fever, 102. A lot of body aches. Took Tylenol for the fever to little effect. The fever disappeared late the next day but the body aches still remains.

3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down /or take any meds/had to miss work/ disoreinted/ just kept sleeping all day and night felt better the next morning... went to work on Thursday 05/ 06/ 2021 felt about 95 % better in about 24 hours......no food and no meds and very week....feeling better now, besides tender stomach from dry heeving

vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown. No concomitant medications were reported. No corrective treatment was provided. 28-Feb-2021, he was hospitalized for vertigo for 3 days. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time. Further information has been requested.

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma) and DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heavy smoker in 2020. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 03-May-2021, the patient experienced PRURITUS (Feeling scratchy). On 04-May-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) (seriousness criterion medically significant) and WHEEZING (Wheezing sounds). On 02-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 03-May-2021, PRURITUS (Feeling scratchy) had resolved. On 06-May-2021, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) and WHEEZING (Wheezing sounds) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Oxygen saturation: 91 Low. On 03-May-2021, the patient was feeling scratchy and mentioned it could be due to pollen. On 04-May-2021, he was experiencing difficulty breathing, which began in the morning and exacerbated by the evening. He had wheezing sound and by 6 PM he could barely catch his breath. He got breathing treatment using nebulizer and his oxygen level was 91. By 8 PM he went to the ER and underwent tests. He was diagnosed to have Asthma and COPD. Treatment: Inhaler, nebulizer and steroid. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

whole body muscle aches, chills, fever over 101, light headed/dizzy (fainted), fatique, some nausea. all disapated within 48 hours of getting shot

Congestion like a head cold, raspy throat, nausea, headache, low grade fever 100. -Tylenol taken for fever

Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:

Headache, Myalgia, Diarrhea, NauseaVomiting, N/A Narrative: 1030hours received dose. 1130hours developed HA not alleviated with OTC Acetaminophen. 1200hours upset stomach, not alleviated with "jell-o" and clear soda, developed nausea. Had 4-5 bouts of BMs from time of dose to 1300hours.

Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee reported being off work since the day of her injection Narrative:

Moderna COVID-19 Vaccine EUA - I have experienced the following : The injection site is very tender to the touch. The soles of my feet have become numb. Slight exhaustion through the first 24 hours after the vaccine.

Felt like he was hit by a bus. In middle of night fever, joint pain 5am 100.2, 6:35am 99.6, 7:30am 99.1 8:30am 98.3, 10:30 98.1.

During the monitoring period, patient began complaining of a headache. Tylenol was offered and given, 1000mg po. Patient was monitored an additional 30 minutes when he stated he was feeling better and was ready to leave.

Started 1/15/21 at 12:30am. Headache, fever (101), Dehydrated, muscle and joint pain (Very Severe) throughout entire body. Could not go to work. Took Tylenol (1000mg) at 10am. Could not rest or sleep. Fever and headache end at 3pm 1/15/21? Took another 1000mg Tylenol at 3pm 1/15/21. Muscle and body pains end at 11pm 1/15/21.

1/18/21 6 PM left arm soreness, took tylenol. Patient states that he started having chills, muscle aches, Patient states that he started having fever of 101 degrees Fahrenheit, dizziness, and tachycardia 1/19/21 at 8 am. Pt. states he took tylenol at 8 am and heart rate and tachycardia improved and dizziness improved as well. Pt. states that he feels good now, but feels like his covid symptoms are light with a cough. Pt. states that arm is still sore.

Patient experienced a headache, nausea, and loss of appetite the evening and day following his COVID vaccination. Patient stated he had previously had Covid several months before and had similar symptoms while he was Covid-positive.

Starts with blurred vision, followed by headaches. Treatment; 600mg Advil Headaches last for about 24hrs

Headache for 48 hours from injection, Fever 100.4 approximately 24-36 hours from injection, weakness and fatigue fir approximately 72 hours

Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatigue, dizziness. Disturbed sleep. Joint pain overnight. Took advil during the night and helped immensely. Following day mild dizziness and fatigue, just feeling slightly unwell. Slept 9 hours that night where normally sleep 6-7. Thursday morning back to 85% and by end of day back to normal.

Onset yesterday (1/21/21) after stretching left shoulder. Felt like itching and mild burning in left deltoid. Rapidly increased to mild pain/discomfort/aching. Went for walk. Upon return, muscle tested and stretched arm to see if I had injured arm. Afterwards, there was onset of pain, swelling, redness, increased itching. Redness generalized over left deltoid with pronounced scarlet redness at site of injection, about 3mm diameter. Today (1/22/21, Day 2 of flare-up, about 22 hours after onset of symptoms): increased aching over entire left shoulder/trap/scapula with pronounced redness over slightly greater area on deltoid, itching at deltoid, hardness and swelling of deltoid. Almost a burning sensation over the deltoid, but not quite. Tissue feels irritated and hot. Limited loss of range of motion. Pain increases with use of left arm, pushing arm through ROM movements. Moderate headache at waking, relieved with 25mg Sumatriptan. Still mild headache. Mild lethargy and fatigue.

Day 1 - Dizziness aches and pains; increased sense of pain in all normal chronic ache locations Day 2 - severe aches, fever of 101.0

severe chills and shaking- bundled up, no other treatment, symptoms abated after a few hours, muscle aches and malaise next day treated with naproxen

COVID-19 Vaccine EUA. Severe pain at injection site approx 6 hours after injection. Weakness, joint pain, slight headache started around 7:00pm 1/23/21 and continue at the time of this reporting 8:00am 1/24/21 If symptoms persist beyond today I will schedule a visit with my primary care physician.

Dec. 29, 2020 - first Moderna Vaccine dose. On same day I had mild localized injection site soreness/pain & felt minimally tired. The next day the injection site was a little more sore/panful & I had moderate headache the whole day. The next day I was fine, Jan. 26, 2021- second Moderna Vaccine dose. Six hrs. later the injection site was mildly sore/painful. 12 hrs. after receiving the dose I began to feel body aches, some chills, decreased energy level & did not fall asleep the whole night. The next day I had moderate headache, continued to have some infrequent chills, body aches, decreased energy level & injection site soreness/pain was still mild but had increased from day before.

Moderna COVID-19 Vaccine EUA. Received 2nd dose on 1/28/21 approx. 10:30 a.m. Approx. 13:30 p.m. ears began feeling warm, left shoulder more painful to touch than first injection, and body slightly sluggish. Left work approx. 17:00, upon arrival home wife noticed my ears were red and I felt very warm. Digital temperature of forehead was 102.7, and ears were 106.4. Took digital B/P and it was 185 / 85. Took two Aleve tabs and sat down to rest. One hour later took temps again and forehead was 100.4 and ears were 102.4. Still felt drained. Removed some clothing, took shower and to sleep. 02:00 a.m. awoke, temps within normal range. Next morning B/P normal as well 135 / 56.

High temperature, difficulty breathing pain in abdomen and ribs. Shallow breathing to try and avoid cough as it hurts so much. Temp in the middle of the night reached 102.4F Chills and uncontrollable shaking.

Hallucinations, Myalgia, Fever, per pt: "flu-like symptoms, chills, fever, tiredness and headache". Took 1 day off from work.

nausea - 30-45 minutes shortly after injection 1/29/21 fatigue body aches - began shortly after injection, continuing but lessened muscle spasms - from 2/2/21 to 2/3/21

Chills with low grade temp 100.4 F starting about 18 hours after the injection Generalized malaise lasted about 18 - 24 hours Profuse sweating the last 6 hours 2.5 pounds weight loss overnight

Moderna COVID vaccine Lot#004M20A-2nd dose administered. At 9 hours I developed moderate chills and shaking with teeth chattering lasting 1.5 hours with full recovery. Myalgias persist into second day.

Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.

Patient did feel itchy all over and ached some after first shot, but didn't say anything about that. Morning after 2nd shot became nauseated; ran fever and ached all over. He felt this was for 2 -3 days, and also very tired. Still very tired on 4th day after shot, but no fever or aching. Patient did take Tylenol, didn't help so also 1 dose of Ibuprofen. Take Prasugrel, so Ibuprofen wasn't really an option for him.

Pain in upper left arm, approx 2 hrs after injection. Nausea, headache, light-headedness: approx 21.5 hours after injection

Fatigued. Retired to sleep at 2/2/2021 @ 1800 hrs. Woke at 2330 hours experiencing pain in right arm, chills and RINGING IN EARS. The ringing in ears lasted 2 days. Bilateral ear ringing. Increased dramatically. Note: In 12/2017 he experienced ringing of ears. 2020 decreased substantially to mild level.

pain and soreness at injection site, chills, fever, muscle and joint pain, nausea, headache, fatigue "symptoms almost identical in type and order felt when I first experienced having COVID-19 in late November 2020, except of course; for the duration of each stage".

Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24 hours after vaccine was administered and still continues. Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue SOB started 24 hours after and continues slightly

severe weakness, nausea, extreme diarrhea, fever, muscle aches all over, headache, shakes, Chronic cough much worse than ever and still is.

a 62 y/o M who presents with concerns for an allergic reaction to the second dose of the Covid vaccine. According to him he got the vaccine around 8:45 AM. He has a history of anaphylactic type reactions with a swelling and urticaria in the past but has not had any symptoms in the last 5 years. He felt sudden onset pit in his stomach, tingling and warm sensations over his face and some chest tightness. He denies all the symptoms currently. He did get medications prior to arrival but states his symptoms were already getting better before he been given anything. He was given epinephrine as well as Benadryl beforehand. He denies any symptoms currently. Denies headache, change in vision, difficulty swallowing, lightheadedness or vertigo, chest pain, sore throat, wheezing, cough, nausea or vomiting, rash, falls or injuries. Denies any recent foreign travel or sick contacts. He did work a full shift yesterday and was coming off a 24-hour shift prior to getting his vaccination. He denies any significant reactions to the first vaccine. Medical Decision Making On initial presentation is an overall well-appearing 62-year-old male who has normal vital signs without fever or tachycardia. He is presenting with concern for allergic reaction of the field to a recent vaccination. The vaccine was given roughly 1 hour prior to arrival. He was given epinephrine intramuscularly as well as IV Benadryl. He states he is currently feeling mildly tired from the Benadryl. He denies any other recurrent symptomatology and feels better. Examination is not concerning for anaphylaxis at this time, no evidence of airway involvement or multisystem involvement. No evidence of local allergic reaction. Low clinical concern for occult infection, metabolic abnormality, ACS or arrhythmia for a cause of his symptoms. He is overall very well-appearing. Labs have been obtained as part of screening for reactions to the vaccination per CDC recommendations including a tryptase and C4 complement. They were drawn over an hour after the vaccine was administered. ECG was within normal limits. After observation patient remained asymptomatic. Did offer steroids, however he wanted to hold off on them as he just got his vaccination which seems appropriate at this time. He was sent home with a new EpiPen. We also gave him follow-up in the allergy clinic. He has any worsening symptoms we do recommend he use the EpiPen as well as call 911. He is understanding. At this point he stable for outpatient management. I did tell him he should expect to feel aches and potentially have inflammatory response to the vaccine, he is understanding of this. Pt was discharged home/self-care. Pt provided strict return precautions, including but not limited to, any worsening symptoms or any new concerning symptoms. Otherwise, Pt instructed to see PCP on an as needed basis.

Fever of 100.0 lasting approximately 12 hours. Slight body aches, lack of energy lasting through 2/13/2021. Largely resolved, by 2/14/2021 a.m.. Pain at the left arm injection site continuing through 2/14/2021. Treated with acetaminophen, 200mg three times daily. Discontinued 2/14/2021 a.m.

Intense Injection site pain. Much worse than first does (in left arm). Fever and feelings of overheating. Chills to the point of not being able to get warm. Sleeplessness and fatigue. Headache and fogginess. All symptoms occurred overnight while in bed. Arm pain remains as well as headache and fogginess after attempting to sleep for 7 hours.

He received the vaccine on Thursday. The left nostril started running, then his eye started getting vision issues on Saturday. He went to sleep and thought it would be better. On Sunday morning he could not stand the sunlight at all, and pain on top of the eye. He went to the ER and they called the eye doctor in. He didn't know what was going on, had blood work done. He told him to FU with his doctor. Gave him eye drops, Ibuprofen and eye cream to go into the eye. He is feeling better today, but when the light hits it a certain way the pain is bad, but it clears. In the morning he has to get used to the sunlight. His eye is red. He is to FU with his PCP.

On Feb 16, day 26 after dose 1, at around 7:30pm I started having continuous Chills suddenly and felt my body temperature rising. I confirmed with Thermometer every 15 minutes, going from 99.1F to 101 F in the span of 2 hours. I took 2 Tylenols (500mg each) at around 9:30pm and started drinking over 1 liter of water, fortified with Electrolytes... My temperature gradually started to go down by 10:30pm and back to normal 98.7 F by midnight... I was worried that I have COVID (my Dose 2 was scheduled on 2/18). I went and did a COVID PCR test which thankfully came out "Negative" in the evening of 2/17. I re-established my Dose 2 appointment for today 2/18 same facility as Dose 1. It is worth mentioning that on 1/29, 8 days after my first dose, I developed sudden itching and redness at the site of the vaccine injection (right arm) and my skin was hardened around the site. Also, this reaction lasted 24 hours and as if nothing happened in next day.

Good night of the injection about 11 hours after I got the injection I started to feel very achy and very sore and then led to shiver passing and turning headache and all of the above the next morning I woke up feeling okay I ate a very small portion of yogurts and oatmeal took two sips of coffee and had to go to the bathroom it was very intense I would stuck in the bathroom for an hour intermittently going number 2 and vomiting very sick and scary the rest of the day I was weak and miserable with a temperature and the temperature lasted all the way until last night it range from one hundred and one point eight two last night at a hundred and 128 I had severe muscle aches after I tip my prod element injection yesterday it which is a Statin anyway that today I feel much better but it was very intense I also developed a swollen lymph node under my left armpit the same arm where they did the injection and it was hot and painful I'm afraid to take the second injection but I want to complete the process if possible

Weakness after exercising 5 hours after vaccination. Chills while sleeping Saturday evening. Sore arm, head ache in early hour of Sunday. Lost sense of smell and taste while eating breakfast on Sunday morning ( 8:00 AM) Mild headache for the remaining of the day, no taste or smell during lunch (2:00 PM). Before going to bed (10:00PM) regain faint sense of smell, took 2 Tylenol. Woke up fine on Monday morning, smell and taste is back to normal.

Approximately 18 hours after taking the vaccine I woke up with body aches and chills. I was also short of breath. The chills lasted approximately 3 hours. The body aches were not severe but lasted 24 hours, as did the shortness of breath. I did go to work on the the 18th (the morning after the shot), but had to leave work early because I was too short of breath to stand up for very long and I also had trouble focusing on my work.

Extreme Sore Deltoid (1st sign progressed over day). The following symptoms started around 9 pm and increased through the night: severe headache, nausea, malaise, other joint pain - especially joints of previous injuries (lifetime), chills, hot flashes, tiredness - though inability to sleep. I needed to take Tylenol through the night which did help with headache. The symptoms were significantly decreased by 6 pm that day (Feb 24th).

Moderna COVID-19 Vaccine EUA: I received my second dose of this vaccine about 9:45am on 2/24/2021. About 7:00pm that same day I began to feel achy. A few hours later I began running a low-grade fever. The worst period of side effects was about 11:30pm - 1:30pm during which I had a fever of over 100,, with aches and frequent chills (pretty much every minute during those 2 hours I would shake with chills even though I felt extremely hot). I was taking ibuprofen at the time (at 7pm and 11pm) yet did not experience any significant relief from the chills & fever until about 1:30am. I continued to feel achy the rest of the night with an off-and on low-grade fever (99-100), despite regular appropriate use of OTC NSAIDS (ibuprofen & tylenol). The fever went away by about 8:00am, and the overall achiness largely went away by 10:30am. At no time did I require any other medical attention.

Patient has had numbness and tingling both arms, weakness of legs and fatigue since 2 days after his Covid Vaccine Jan 6th. Has had 2 syncopal episodes since then. Had a syncopal episode Feb 15 and again 2/26/21

Intense chills and muscle cramps. I put on insulated underwear and got some control over shaking. Took 5 ibuprofen and was able to get a few hours sleep.

Dizziness started approximately 30 minutes after injection, weakness approximately within two hours along with extremely tiredness. Muscle pain in left leg started approximately 24 hours after injection.

Very tired the evening of the vaccine (3/1/21) Flu-like symptoms on 3/2/21: tired, headache, body ache, No fever though Better after noon on 3/3/21

3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen every 4 hours. Around 2:00pm, uncontrolled shivering due to chills started. By 3:30, had muscle\joint pain in back and began feeling lightheaded. At 5:30, was unsteady on feet, pounding headache, fever of 101.8F and no appetite for dinner. Fell asleep on couch, woke at 7:30 pm, discontinued ibuprofen and acetaminophen, took 500mg Excedrin, fever of 102.8F and went to bed. Uncontrolled shivering resumed around 8:30pm, woke up several times during the night drenched in sweat and took ibuprofen at 4:30 am. Awoke at 8:30 am on 3/4 drenched in sweat again, took hot shower, had light breakfast and took 500mg Excedrin. Temperature is currently 99.3F

Fever and terrible chills about 12 hours after receiving the shot. Lasted about an hour. Woke up the next morning with mild fever, headache, aches, injection site very painful. Started taking Tylenol.

Initially severe chills, joint aches all over, dry cough after 1 day. That went away after 24 hours. Then a severe pain only at the Left Iliac Crest and surrounding muscles. At times very difficult to bear weight or ambulate up steps. Continues tenderness in muscle area just above Iliac Crest. Pain and weakness varies with no particular rhythm. Pain varies from 2-3/10 to 9-10/10 that takes breath away. Pain and tenderness continue to this day.

After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.

Extreme fatigue, swollen lymph node on left side of neck, sore jaw, sore nasal cavity, headache. No treatment and still recovering. Feeling a little better each day.

Sweats beginning about 11pm, 10 hours after injection and lasting all night. Low grade headache beginning 11pm, still continuing Aches, lethargy

Experienced chills and slight fever (100.8). Treated with Tylenol. Adverse Event resolved the next day.

Initial site soreness and two days of flu like symptoms, mild headache, muscle soreness/body achs, fatigue, after second dose. Fatigue has persisted to this date

Swollen arm at injection site; swollen hands, fingers, and feet; headache (forehead); painful joint inflammation in fingers, shoulders, knees.

Approximately 12 hours after injection, had horrible chills off and on for several hours with fever. The following night, the fever spiked to 103.6 and stayed above 103 for several hours. Fever finally broke 3 days post injection. Injection site was very painful and is still somewhat painful after 4 days. Experienced body and muscle aches, nausea and headache. Still experiencing nausea and dizziness 4 days after the injection. Have been taking Tylenol on a regular basis and pushing fluids.

Woke up at 2:00 am extreme headache I took ibuprofen 200 ml. 7:00 am very weak headache not as bad. Day 2: dull headache, very fatigued, muscle ache between shoulders into upper neck. Day 3: same as Day 2. Day 4 same as Day 2 but now small rash on hip. Day 5 dull headache and rash, not fatigued and no muscle aches. I hope this info is helpful.

I had chills and sweat the bed the first night which was a Sat. Was exrtremly achy all over. Next day was again extremely achy and that night i went to bed right after supper and slept 12 hours, Again very achy and again sweat the bed all night and woke up on Monday just fine. Aches are gone but have continued to sweat the bed each night. Not dramatically but just slightly these past 2 nights

Low grade fever (100.4) General acheyness, Chills all lasting about 21hrs Took Tylenol PM at bedtime

I started feeling bad on Tuesday the ninth at 8 PM fever sweating chilling severe headache joint pain and I didn?t start feeling Little better until Thursday The 11th at 10 AM but still having spells where I?m sweating and chilling I went to bed At 8 PM on Tuesday the ninth and did not get up until 10 AM on Thursday the 11th

I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to ask if I should get the second one? I was able to get an appointment for a Covid vaccination thru store/pharmacy. I had the shot about 4:00 on Friday. On Saturday about noon I started not to feel right; head ache and stomach. About 4:00 I started to get an increase in my temperature. At 5:30 I started getting uncontrollable shaking. Over a span of about 30 minutes I had 4 or 5 episodes that lasted 30 - 45 seconds. I had a temperature at one point that reached 102.3 I took 200 mg of Ibuprofen every three hours before falling asleep for the night. On Sunday morning I still had a slight temperature (99.9), but it seemed like all my body joints ached. I ended up feeling better about 4:00 on Sunday. Reply

Note: *I did test positive Covid-19 in November 2020, had full recovery and symptom free 90 days before before receiving vaccine.* 1st Dose @ 10:30 am on a Saturday. 45-60 minutes (11:30 am)after dose. Light headed and dizziness. By 4:00pm body & joint aches. @ 7:00pm- Chills started with 99.8 fever. @11pm fever @ 100.6 with bad cold chills. Fever and Cold Chills progressed over next 30 hrs. peaking times @ 101.2. On Monday approximately 4 am fever broke to 99.2, bounced up and down over next 6 hrs. before dropping below 99. By end of day on Monday. 48+ hrs. after 1st dose, No sides effects other than fatigue from experiencing side effects

Severe headache began on 3/5/21. Headache continued off and on for a week and still has headache to day.

Fever, malaise, joint pain, headache, and pain for two days. Injection site swelling for four days so far. Red, tender hemispherical mass the size of a softball in my left axilla.

Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue

Pain at injection site - began day after injection and lasted about 3 days Fever - began two days after injection and lasted about 2 days Headache - began day after injection and lasted about 3 days Fatigue - began day after injection and lasted about 3 days Sensation of dermal scratchiness over torso and legs (no visible rash) - began day after injection and lasted about 7 days

Approx 12 hours post injection woke in night with chills and fever. 101.5F fever persisted through the following morning until early afternoon. Flu-like symptoms; fever, body aches, low appetite, fatigue, chills. High fever reduced with acetaminophen. Bed rest through afternoon and fluids. Body aches and fever dissipated by 36 hours post injection. Return to normal health by 48 hours.

The patient reported feeling a rush of blood to his head and then head pain localized in his forehead about 10-15 minutes after receiving the vaccine which lasted for about 5 minutes. He then reported having a strange taste in his mouth about 15-20 minutes after receiving the vaccine which lasted for 10-15 minutes. All of these reactions resolved on their own by about 30 minutes after the vaccine before he left the facility.

Patient reports racing heartbeat, diaphoresis x 2 days, reported to hospital with a HR of 75, but was instructed by Hospital for patient to have VAERS filled out.

The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The stiff neck and headaches and general malaise has persisted throughout even until now. As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.

Patient reports feeling a little dizzy, pressure on his head, ringing in his right ear. Felt better after a few minutes. Cleared by EMS

Patient started within 6 hours having joint pain and chills. Chills lasted about 5 hours, but joint pain in all joints on left side of the body never left and is still present currently.

Shot was given in the left shoulder joint. Because most of the vaccine would not go in, a second vaccine was given in the right arm. On March 19, 2021 woke up in the middle of the night Wet with sweat.

On Friday (05.19.2021), fourteen days after receiving the first dose of the Moderna COVID-19 vaccine (on 03.05.2021) at pharmacy, I began experiencing body aches (mostly leg cramps) followed by nausea, headache, and fatigue. They continued through the next 36 hours. Today (Sunday, 03.21.2021) the headache subsided, but the nausea and fatigue remain, albeit less so than yesterday. I had similar symptoms in the first 24 hours of receiving the first dose but understand that to be a very common experience.

Fever headache chills muscle aches redness on left arm and swelling took about 40 hours to get over it

Patient received the first vaccine 03/04/2021. Patient was contacted to return to the clinic for his second injection and patient received the second injection 03/16/2021. Scheduling staff contacted the patient to schedule the second dose and the patient stated he had already been to the clinic and had received the second dose. Scheduling staff notified the clinical supervisors of the event. Patient was contacted by telephone 3/25/2021. Patient stated his arm was sore after each vaccine and he had a headache the day after the second vaccine, but no other adverse reactions were reported. Patient was instructed that he should not get the series repeated and patient was instructed to notify the clinic with any questions or concerns. The patient was receptive with conversation.

Chills, extreme body/joint aches, very sore arm, fatigue starting the evening of the vaccine , lasting yet today 3-26

Itching in 10 minutes followed by reddening of skin and red splotches, extreme headaches, body aches, fever, sweats, chills, cough, nausau, swelling of lymphs nodes in chest and groin, shortness of breath, and light sensitivity.

Severe chills, fever 101.5, fatigue and headache started at 11:30 pm Thursday night . Fever, fatigue persisted through Friday even tough taking Tylenol. It would drop to 99 with Tylenol, then spike to over 101 at 6 hours (right before next dose of Tylenol was due). Fever broke Friday night, continuous sweat for 6 hours necessitating bed change at 4 am. Saturday morning temperature normal, no symptoms left.

Woke up with chills, headache, and sore muscles. Did not take my temperature, but felt flushed. Felt lethargic the whole day after the shot (2nd dose of Moderna COVID-19 vaccine).

Arm was a bit achy later in day I received the shot but nothing bad. Started feeling chilled about 11:30 pm the day of my shot (Saturday). Woke up about 2:30 am Sunday with chills and sweating. Woke up several times during the night with chills and sweats. Started having slight headache during the night. Took a couple of Tylenol. Woke up about 9 am day after shot (Sunday). Was very tired but chills and sweating were gone still had slight headache. Was exhausted remainder of day. Just stayed in bed and rested entire day. Started to feel better later in the evening about 8:30 pm. Went to bed about 10:30 pm and slept until 9 am Monday morning. All adverse effects were gone.

patient experienced shallow breathing, hives, sweating and low systolic blood pressure 85 within 5-10 minutes of receiving first moderna covid vaccine. Had pt lie down on his back and administered epinephrine 0.3mg on thigh within 5-10 minutes of monitoring pt. Patient became more alert and sbp came up to 110. EMT came and took him to er

Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,

3/25/21 developed chills, muscle aching, diarrhea evening of vaccination--symptoms continued for 48 hours with poor appetite/nausea. lost 4 pounds over the next few days. 3/28/21 c/o dizziness, heart fluttering/irregular. 3/30/21 saw dr, and EKG showed afib. medication changes. 3/31/2021 repeat EKG a flutter. admitted observation to hospital. NOTE: Does have a history of episodic afib/flutter--no episodes for the last few years

I had the usual symptoms, but one symptom I don't see anywhere. Usual: Sore vaccine site, body aches and pains, headache, tiredness. I was unable to sleep due to the symptoms the first night. I convalesced the entire next day and tired easily for the next two days after that. Here's the unusual side affect: I had uncontrollable and very painful leg cramps, that I could not relax. I had to take a muscle relaxer. That was the night of the second vaccine. The cramps were abated thereafter. I am reporting them because I saw them as a side effect no where online.

Starting approximately 18 hours after first dose on 3.01.21: Severe migraine-like headache for 24 hours (I have experienced severe chronic migraines for the past 35 years, so I know what I'm talking about) Flu-like body aches for 48 hours Vomiting and nausea for 48 hours Sweats and chills for 36 hours, but no fever All I wanted to do for two/three days was sleep After second dose on 3.29.21: Some body aches and general malaise, but nothing dramatic like after the first dose

Got the vaccine on 3/26/21 had no problems, and then Saturday morning at around 3:00-4:00 he had a sore arm, nauseous feeling and threw up water a couple of times, and did not eat. He finally ate something that evening, and started having left arm pain, aches and pains. He was having chills, and then fell asleep again and woke up in sweats. He also developed some diarrhea going into Sunday, and Sunday morning his temp went down, his blood oxygen went up and started feeling better. He also still had some chills, and very little sweats than before. On Monday he felt better, his blood oxygen was back to 100, temperature was better. On Tuesday he felt much better and by yesterday 3/31/21 he felt back to normal again. He did take some Tylenol and Ibuprofen for his symptoms during the course of the event.

Awoke between 2am and 3am with chills and fever of 99.9f. The chills lasted about 15 minutes. I awoke two more times during the night with chills also. The fever persisted until about 5pm that evening. However, there were no more chills. I also had injection site soreness for about 36 hours.

106°F fever; severe shakes; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106°F fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERPYREXIA (106°F fever) (seriousness criterion medically significant), TREMOR (severe shakes) and FATIGUE (very fatigued). At the time of the report, HYPERPYREXIA (106°F fever), TREMOR (severe shakes) and FATIGUE (very fatigued) outcome was unknown. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Pain in L hand and fingers woke me up from sleep at about 430am on 3/26. When making a fist, felt clicking on pinky. Felt and LOOKED like TENDON GLIDE ISSUE (based on my occupational therapy knowledge-base). Believe I did a ice message (I usually don't initiate warmth till after 1st 24 hours.) Did tendon glide exercises and later did a functional activity (washing dishes -squeezing the sponge). Resolved post about 1 hour without need for medications. Need to maximally avoid taking NSAIDs due to my chronic mild platelet issue. Do NOT recall any musculoskeletal issues on the L upper extremity. 3/26 not recall onset of symptoms - believe near noon - Significant Headache & Fatigue x several hours. Slept several hours. May be related to being awake in the middle of the night & PMH of mTBI w/residual symptoms - .

patient had a fever for 24 hours, increased heartrate for 24 hours and a tingling that started around the injection site and traveled to his elbow and down to his fingers. He also had a tingling on his left leg. This tingling started about 24 hours after the shot and is still continuing to occur. The tingling is only on his left side which is the side of his body that received the shot.

Fever 102.3, muscle pains, and blurred vision for 3 days, which has not been reported among side effects of this vaccine by CDC

Fever, chills, nausea, headache, injection site pain on the first day after shot on March 26th. On day two after injection all the other symptoms subsided, but headache continued. On April 1st the fever, chills,and nausea returned and temperature had reached 100.8 degrees and headache intensified. On April 2nd I woke up feeling better but still had the headache, as the day progressed the chills and fever returned with temperatures up to 100°. On April 3rd I woke up with no temperature but the headache continued. On April 4th The headache finally went away. My treatment was plenty of water aspirin, ibuprofen, acetaminophen and bed rest.

*Vaccination administered on March 11, 2021. (Moderna) *Donated blood platelets on March 21, 2021. (This process was exhausting for patient.) *Numbness and tingling in the left foot begins on March 30, 2021. ** Patient had Guillain-Barre Syndrome back in the fall of 1996, so the numbness and tingling were a red flag. By the time patient was admitted into the hospital on April 6, 2021, he was experiencing numbness and tingling in both feet and tingling on the finger tips of both hands.

Received the vaccine Saturday am 3/20/2021. Saturday pm had numbness in right foot that lasted a few minutes. Headache off and on started Sunday 3/21/2021. No medication taken for headache. On Tuesday evening 3/23/2021, driving home from work had a sensation of something being wrong. After arriving home at 7 pm had a short term memory loss. Could not remember details of the day, for instance, or that he'd already had the Moderna shot three days prior. Was driven to the emergency room at about 9:30 pm. Memory gradually improved over the hours following the spell. They kept him in hospital until 3/25/2021, doing tests to rule out stroke, seizure, brain tumor etc. All tests came back negative. Was diagnosed with Transient Global Amnesia.

he received Moderna vaccine on 03/15/2021 and on 04/13/2021. On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911. Per neurology consult 4/15 - "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something. He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words." Tm 103.4. On exam 4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements. + headache. Keppra and / or mirapex, then ativan later, seemed to help. Symptoms had completely resolved by 4/16/21.

Headache Joint pain Back pain Eye pain Fever shaking chills Fatigue Tiredness After a week tiredness still present and moderate fatigue

Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to confusion, fever and loss of cognitive impairment. (unable to walk and speak) speech was out of context) and loss of muscle use and fever.

Patient sitting in lobby for recommended 15 min observation time. He burped loudly, vomited (green/yellow vomitus), slumped to his right in the chair. Patient was diaphoretic and slow to respond to verbal stimuli.

I woke up at 3:10 am feeling cold and chilling. I took by temperature and it was 98.4. I normally have a temperature of 97.1 - 97.7. I take it daily multiple times. My hands were cold. When I got up and started moving around I didn't have any more chills. When I got up at 6:30 am. I just didn't feel well in general. Slight feeling of sniffles, congestion. I would get some aches that went away in a few seconds. They were at various points in my body, knee joints, muscles, and my head. They were simply a nuisance. I felt tired all day. My blood pressure was up 15-20 points on both numbers during the day. I've told my doctor when my blood pressure is higher, I'm having more aches and pains as though I'm fighting a virus. I tolerated the symptoms most of the day, letting my immune system try to work it out. My symptoms seemed worse at 5:45 pm, so I took two ibuprofen. My temperature was 98.9 at that point. The highest it's been. All my symptoms got better until 1:15 am. I woke up feeling like I was chilling, but not as bad as yesterday, so I took two more ibuprofen. I feel 50% better today and haven't taken any ibuprofen. Here is the really strange part. I had these exact symptoms and similar temperature ranges twic last year. In July and October I think. I didn't get tested last year because they were minor symptoms. They were just nuisance symptoms. I took ibuprofen right away last year. I followed the masking guidelines, social distancing, etc. So, is it just coincidence I had similar symptoms last year two times, that I had when I getting the inactive Moderna vaccine? I had no reaction to the first shot. I just wanted to provide the information in case it is helpful. Very strange. I expect no other symptoms in a couple of days.

hallucinating; full day spent in bed feeling bad; chills; Body Aches; A little bit of a fever; didn't eat for 2 full days; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 virus test positive (Patient with a prior, confirmed COVID 19 Infection requiring a ventilator in October and November.) in October 2020. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FASTING (didn't eat for 2 full days), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (full day spent in bed feeling bad). On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant). On 24-Apr-2021, HALLUCINATION (hallucinating), FASTING (didn't eat for 2 full days), FEELING ABNORMAL (full day spent in bed feeling bad), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient took Blood pressure medicine(Name Not specified) and aspirin as a concomitant medication. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21.

Bells Palsy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 25-Apr-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown. Action taken with the mRNA-1273 in response to the events was not applicable. Treatment medication are Valacyclovir, Prednisone and Gabapentin. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Recieved obituray on patient. Called pt. ER contact and she stated that she was unaware how patient died. Pt. died at home but states that pt. had been having flu-like symptoms in bed with chills after vaccination. Pt. ER contact is unaware of pt. medical history or current medications. Pt. ER contact that pt. PCP was not us but another medical facility. Called funeral home and spoke to employee and she stated that the coroner cause of death listed was acute MI. Employee stated that she does not have a certified copy of death certificate at this time.

Woke up with head-spinning dizziness the first night the symptoms started. Since then I've had regular headaches and an ongoing sense of subtle lightheadedness. The dizziness returns if I move my head too drastically, particularly if I lie down quickly in certain directions. If I am careful through the day I am not dizzy but there's the lightheadedness. Existing tinnitus also seems aggravated.

Patient reported fatigue and progressive weakness since given vaccination. Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.

I had a slight sore throat on night of getting vaccine. On the day after, I had chills, body aches, chest tightness and pain, shortness of breath and Wheezing.

True vertigo - room spinning dizziness, perceived motion, made worse with changes in head position. Nausea and vomiting at extremes of vertiginous symptoms. Also generalized fatigue noted. No fever, chills, diaeresis, headache, hearing loss, loss of taste or smell, cough, or nasal congestion, muscle aches, body aches or myalgias.

Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188. We had him lay down and about 10 minutes later his blood pressure was 140/70. After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.

Injection site soreness that was worse over night Headache this morning that would not go away. Has been taking Ibuprofen and Tylenol and just now Tramadol in repeated doses for relief. Fatigue

RASH STARTED IN THE ANTERIOR WAIST , AND BIALTERAL LOWER LEGS ABOUT 30 HOURS AFTER VACCINATION. THE RASH EXTENDED TO THE ANTRIOR PELVIS, THIGH , UPPER ABDOMEN, ANTERIOR NECK AND FOREARM, AND EXTEND TO THE UPPER ARM IN 48 HOURS. THEN ABDOMINAL RASH DESAPPERED. NO-MINIMAL ITCHING, NO FIEVER , NAUSEA OR DIARRHEA. MINIMAL HEADACH AND ABDOMINAL PAIN. NO TREATMENT.

Person had a fever of 102.4, pulse rate of 118, he was non-responsive with edema of the right calf & ankle this morning when he was assessed.

increase temperature 99.6-103, elevated Blood Pressure 196/128, Heart Rate 115, mild light headedness, no shortness of breath, alert and oriented

Headache, Myalgia, Arthralgia, Flu-like symptoms, woke up slightly restless on eve of 23rd, increased nasal congestion, profound fatigue following 48hrs difficult moving/getting out of bed, severe low back pain, left deltoid sore x 3 days, chills no documented fever, alternating Acetam Narrative:

Developed chills and fever approximately 12 hours after shot. As I had the Covid 19 in May, (tested negative on the 18th May, positive on 21st May) the symptoms are very similar. Except for no loss of smell or taste. Moderate to extreme fatigue at this point 72 hours later seem to be the only lingering effects with some light headedness.

Symptoms were first noticed the following day of the vaccination at at 6 AM. They were chills, hands and feet being extremely and unusually cold, fatigue, body aches and soreness at point of vaccination. Body temperature increased but not to above 98.6.

Head ache, Chill, Fever (100.4 to 100.80), Body ache, Light burning eyes, loss test for 2 days. Took Tylenol x2 (500mg) for 2 days.

Started running, body aches, chills and experiencing extreme fatigue about 11 hours after injection. Took Tylenol and drink plenty of fluids. Reports being sick for about 48 hours.

Moderna COVID-19 Vaccine Extreme dizziness except when laying down since waking at 5am. Nausea with several episodes of vomiting earlier has subsided, but I'm afraid to eat or drink and get sick again. Severe fatigue and tiredness which are both unusual symptoms for me.

On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.

Same night of vaccination on 12/21/2020 I felt a little pain on my shoulder and a little fever of 100 degrees & on 12/25/2020 I started feeling sick I started with a runny nose & I had a little fever as well. On Monday 12/28/2020 I went to go get tested for Covid & it came out positive & Type B flue.

Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia.

on the day of 01/15/2021 around 2PM Chill and fever to 101F then took Motrin and lasted for 4 hours before it disappear the fever.

Thursday Nite starting at 11 PM: A warm feeling at the top of my head like a heat lamp. Lasted 15 Minutes. Then Left Leg, Two Toes start pulsating/shaking uncontrollably. I rubbed with the right foot...it would stop...then start back up. Lasted 30 Minutes. Then my chest started feeling like I had a bad sunburn on my skin. Lasted 30 Minutes...all the while these strange things were going on, I noticed I had asthma. I ONLY get asthma if I have a cold or flu. I thought to get up and take an inhaler but decided against it worried about an adverse reaction to the vaccination. I fell back to sleep and awoke with no asthma and all strange symptoms gone. Then Friday afternoon I developed chills and a queasy stomach (belching and gas and loose stools.) I checked my temperature (on multiple occasions) and it was normal. These two conditions lasted until Saturday. Also on Saturday, I developed aches in my neck. Then very late Saturday Night, I awoke to a sweat drenched tee shirt but chills were gone. Sunday...today....I feel perfect.

8/10 arm pain, chills , fever, malaise a few hours after 2nd dose. Sx slightly improved today. First dose with minimal SE's.

Headaches, tiredness. Sunday still had headaches but worse after waking up. Started developing severe SOB, stomach ache. Early evening, had diarrhea until the next morning. Monday still had SOB, and headache. By Tuesday, SOB had kind of went away but still had headaches.

Saturday, headaches and tiredness. Sunday morning still had headache, later developed SOB, difficulty breathing, feeling sick, and diarrhea. Monday, headache and SOB throughout the day. Tuesday, SOB had gone away but still had headache.

Was fine after receiving shot. Woke up at 4: 00 a.m. next morning with 101.5 fever. Took Tylenol but would not go down. Called primary doctor. Told me to take ADVIL. Still would not go down. After hours and very weak, called 911 and ambulance too me to the hospital. Arrived and they too vitals. Still high fever. Blood work showed high white blond count. stayed at hospital until late at night. Fever went down. Told me some people have thee type of issues with Moderna. Checked brochure Moderna provided says fever but not High fever. Doctor dismissed me from ER and told me to rest the next two days. I had Covid in October 2020. They wnet ahead and did another test. Waiting on results

Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Began experiencing severe chills, headache, joint ache, fatigue, muscle ache, fever 12 hours after injection. Symptoms continued for additional 48 hours. Unable to report to work for that time.

Patient became febrile after receipt of vaccine: 103.2 degrees F. Attending medical doctor assessed patient and ordered a COVID swab and urinalysis to rule out infection. Fever waned overtime but remained slightly elevated (low-grade fever) and continued to be monitored by staff. Patient was given acetaminophen (dose and frequency unknown).

Soreness in left arm, tiredness approximately 12 hours after receiving vaccine; symptoms were gone the next day.

The patient received his vaccine on Monday 2/1/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 101.7 F. Since the patient was febrile, he was given rapid COVID tests, which was negative. He was not in distress. He had no complaints otherwise.

The patient received his vaccine on Monday 2/1/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 101.3 F. Since the patient was febrile, he was given rapid COVID tests, which was negative. Patient received acetaminophen. He was not in distress. He had no complaints otherwise.

Symptoms of an enlarged spleen; Blood in stool that lasted 3 days; General tiredness; A spontaneous report was received from a dentist, a 63 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced general tiredness, blood in stool that lasted 3 days, and symptoms of an enlarged spleen. The patient's medical history, as provided by the reporter, included high blood pressure. No relevant concomitant medications were reported. On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 026L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis. On 04 Jan 2021, the patient had general tiredness. On 16 Jan 2021, the patient experienced blood in his stool. On 17 Jan 2021, the patient had symptoms of an enlarged spleen. He stated that he had intense pain on the side of the spleen. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, blood in stool that lasted 3 days, was considered resolved on 19 Jan 2021. The outcome of the event, symptoms of an enlarged spleen, was considered resolved on 19 Jan 2021. The outcome of the event, general tiredness, was considered unknown.; Reporter's Comments: This case concerns a 63-years-old male patient, who experienced a medically significant unexpected event of blood in his stool, and non-serious unexpected event of Symptoms of an enlarged spleen along with expected non-serious event of General tiredness. General tiredness occurred on the same date after the first dose of mRNA-1273, lot # 026L20A. The event of blood in his stool occurred approximately 12 days after first dose of mRNA-1273, lot # 026L20A. The event of Symptoms of an enlarged spleen occurred approximately 13 days after first dose of mRNA-1273, lot # 026L20A. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Approximately 5 days after receiving 1st dose of vaccine, patient woke up from nighttime sleep feeling 'itchy' all over body. Found approximately 10 red, raised spots or 'welts' on skin that he had never seen before. They were sporadic, NOT clustered. He described as not quite hives. He checked bed for 'bugs' but didn't find anything. He had taken metaxolone for only the second time in his life before bed. Prior use did not elicit any type of 'rash' as described. He applied no topical nor ingested any oral medication at this time. He mentioned he has IBS and also had 1 instance of diarrhea. He then took 1 imodium. He was able to eventually fall back asleep. When he awoke the next morning, all but 1 spot were gone and no indication this had ever happened. He has experienced a mild headache off and off since injection, but nothing significant that keeps him from his normal business.

Two days after vaccine I experienced a chronic headache for over two weeks which I have been treating with Tylenol (six per day) Today is the first day where symptoms seemed to have eased

Bronchitis; COVID-19; A spontaneous report was received from a consumer concerning a 63-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and bronchitis. The patient's medical history, as provided by the reporter, included asthma and unspecified allergies. Concomitant product use included unspecified allergy medication and asthma/bronchitis inhalers. On 02 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced coughing, wheezing, shortness of breath, headache, and sinus congestion. The patient tested positive for COVID-19. The patient was taken to the hospital where he was treated with an infusion. On an unspecified date, a computed tomography scan showed bronchitis. Additional treatment for the events included unspecified antibiotics and steroids. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events COVID-19 and bronchitis was unknown.; Reporter's Comments: This spontaneous report concerns a 63-year-old male patient who experienced the serious events of COVID-19 and bronchitis. The event occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). Treatment administered included antibiotics and steroids. Outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported events and mRNA-1273 vaccine administration. Critical details such as diagnostic test for COVID infection prior to vaccination was not ascertained. Causality is also confounded by the patient's advanced age. Main field defaults to ‘possibly related'

12 hours after receiving my second moderna vaccination I started to get a fever of 101. Throughout the night I fought the fever with Tylenol. The following morning I still had a fever of 100, but also great fatigue, nausea, headache, and general body ache. From the on set of my first symptoms until they completed was 30 hours.

My oxygen levels dropped below what they had been previously as I am recovering from Covid infection tested positive 20 October 2020. If I do anything at all other then set my oxygen levels would drop into the low 80's. I have also been monitoring my sugar levels. I am not diabetic but did so because in ICU was using steroids which elevated sugar levels. I continued to monitor it at home because I had to do injections for several weeks after leaving the hospital. Have not had to use insulin til the other day. Vision is very blurry. Had that problem in the hospital but it has gone away but since I had the first vaccine everything is now blurry. Left leg hurts to put weight on the heel. I have nerve damage to the left leg but this is a unique issue. I'm running a low grade fever 100.2 - in the morning it is normally 96.5-97.6 and this temperature was in the morning the day after the shot. Neck is very sore. I have rods from C3-C6 and the pain is in the muscle glands closer to the surface. It is almost like it is attacking all areas of the body I previously had issues. I spent October 25 - November 13 in Hospital, majority of time in ICU.

Muscle pain and cramp like symptoms mostly in legs over night for 6 days, fatigue, loss of weight and appetite

2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on the signs of Stroke "FAST" Patient Issues: Physical shaking like Parkinsons , Heart Palpitations and rapid BPM, Chest Pressure, shallow breathing, stuttered speech, Slurred Speech, Headaches, Confusion and lack of short term recall, red flush face, difficulty in comprehending conversations, reading

1/31 - received 2nd dose of Moderna vaccine at MD (where I work as M.D.) Approximately 8 hours later, experienced severe chills, fever 102, chest pain, and shortness of breath. Fever lasted two days, however ,still not feeling well then experienced palpitations, irregular heartbeat. Went to cardiologist on 2/8. Tests revealed pericardial effusion and pleural effusion.

Day 1: sore arm, fatigue, headache Day 2: headache, fatigue, chills, mild nausea, body aches, joint stiffness Day 3: sore arm, fatigue, lower back pain, chills at night Day 4: sore arm, a period of body aches, a phase of fatigue, sudden lower back, neck, and knee pain Day 5: sore arm, fever, chills, lower back pain, stiff joints, neck pain, headache

Approximately 18 hours after receiving the vaccine, I developed a fever ranging from 101-102.4. I had muscle aches and for a short time, blurred vision. After resting for approximately 12 hours, taking Tylenol and drinking water, my symptoms subsided.

H/A - moderate to good relief with acetaminophen 750 mg , 2 doses over 24 hours; intermittent chills, generalized achiness - some relief with acetaminophen, some fatigue

Received 2nd vaccine in morning at 10am, that night at Midnight started a fever. Fever of 102.2. Fever lasted for 24 hours. Muscle aches and pains, joint pain, lower back pain right side, headache. Fever broke after 24 hours. Some continued weakness for a couple days. Then back to mostly normal. 10 days later, mild fever returned in the evening of 2/9, and 2/10, temp of 101. These second rounds of fever went away during the day. And temp was between 99.8 and 101.2. My question is: Is it normal to get a mild fever 10 days after 2nd vaccine shot?

2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence 2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise, cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement

high fever unresponsive to tylenol, muscle pain and weakness, sore arm, joint pain, mild shortness of breath, headache

Fever 100.1. Nausea. Joint pain. Fatigue. Chills. Pain redness rash swelling at injection site. Rash still on 2/14/2021.

Severe arm ache at injection site. Headache. Slight Fever Tired Could not sleep General poor feeling All took place early morning right after shot

Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Developed Bell's Palsy left side of face 96 hours after vaccination, after having neck stiffness and headache that started 48 hours after the vacc. Condition diagnosed by family physician.

Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination. He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A). He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies. He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome. He was ultimately discharged to outpatient care with ongoing supportive care for his fevers. His liver associated enzymes were improving at discharge.

Patient experienced Chest pain & was diaphoretic approx 5 minutes after vaccination. Onsite EMS was called vitals BP 168/107 HR 63 100% O2 room air. No past reaction to vaccine, last flu vaccine in September. Patient said he was feeling better after approx 10 minutes. Relased to home.

I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs. I then tried to drink cranberry juice and eat 3 bites of a banana which I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days

Developed chills, mild headache, mild upset stomach within twelve hours of vaccination. Persisted until the morning of the 24th.

Blood stain streaks bright red in feces; Nausea; fatigue; Headache; Diarrhoea; Feeling gassy; Fever; Vomiting yellow bile; A spontaneous report was received from a consumer regarding a 63-year-old male patient who received Moderna covid-19 vaccine and have experienced blood stain in faeces, vomiting, nausea, headache, flatulence, fatigue and fever. The patient's medical history was not provided. His concomitants include Baby aspirin (blood thinner),Potassium(for low potassium),Gabapentin(for pain),VitB12(for nerves),Duloxetine Hcl (Neuropathy),Doxazosin Mesylate ( for prostrate),Lisinopril(for hypertension),Simvastatin(for cholesterol) and Alprazolam(anti-anxiety).No information on allergies. On 10-FEB-2021, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine intramuscularly for the prophylaxis of covid-19 infection (Lot#015M20A). On 11-FEB-2021, he vomited yellow bile looking stuff, had diarrhea, fever and felt gassy. On 12-FEB-2021, he no longer felt vomiting, but felt nauseous, slight fever, fatigue and headache. On 13-FEB-2021, he felt nauseous and had blood stained faeces (bright red). Caller was informed to consult physician for treatment and her question regarding second dose for her husband. Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported. The outcome of the event vomiting is recovered, but other events are not recovered at the time of report.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Severe chills, shaking and fever lasting 6 hours. Fatigue lightheaded dizziness vomiting next 2 days +

Day #1-3-- >Sore arm, edema to the site (resolved after day #3) Day #5-- >Symptoms include fatigue and increased stomach upset. Routine labwork drawn on 2/19/21 (see results below). Will be having labs redrawn on 3/5/21 and will see the hematology oncologist on 3/16/21.

fever (102.7), sweats, and chills starting about 24 hours after receiving my second dose, but symptoms are declining quickly 24 hours after onset.

Resident received 2nd dose of COVID vaccine 3/3/2021 at about 11:00am. At 18:08, primary care nurse at that time checked VS and noted resident's temp to be 100.2 with nausea and vomiting. by 18:15 resident temp was up to 102.1 and SaO2 83% and was placed on oxygen via nonrebreather mask. 911 was called and transported resident to hospital.

About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to the top of my head. It almost like little shocks going thru my body. I had a video appointment with my Dr. and he prescribes doxycycline and prednisone. The next day the fever went away and started to feel better (48 hours later). I also tested positive for Covid on 12/24/20, I didn't wait 90 days before I got my vaccine. I felt awful with the second dose, almost worse than being in the midst of Covid. I'm currently on Workman's Comp. I'm constantly out of breathe and have no energy, I use to have tons of energy. From my atoms apple to my sternum I have tons of pain. My lungs feel like I'm smoking and have tons of pressure. My Dr. ran test because I have the worst head aches. I'm like slow motion.

Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134. MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93% and 97%. Client continued to be diaphoretic, pale, also shaky

I felt fine the day of the shot. During the early AM of the next day, I felt significant body aches. As the next day unfolded the other major symptoms included Fatigue, chills, fever of 101, headache and body aches. I got into bed at 3PM Wednesday afternoon, continued to have some combination of the symptoms adding night sweats. The next morning, all symptoms cleared. Body temperature was back to normal. March of 2020, I had severe Covid illness. I was in bed from March 18 to April 1, then Hospitalized April 1 to April 6. It took me until about the first of June 2020 to recover and rebuild stamina. I had brain frog until Nov 2020 neck and headaches until the present time (March 5, 2021)

Headache started ~ 1-2 hours after injection and lasted ~ 4 hours (treatment was nap and no activity). ~ 8 hours after injection arm pain near and around injection site. Still present with slight rise in pain level after 1st night.

12 hrs after vaccination (upon waking in morning) temp was 101°; throughout the day it was accompanied by severe fatigue, and continued to rise to 103° at it's highest that night. Treated with acetaminophen, fluids and bed rest. By morning, the temp was close to normal, and stayed relatively low from then forward, with no further treatment required. Fatigue continued, but improved steadily through the 6th & 7th.

3hrs following injection severe headache 12 hours following injection 102- 105 fever lasting 24 hours. Tylenol dropped the fever from 105 to 102. Accompanying fatigue, weakness. Unable to get out of bed for 24 hours. Fatigue continued for additional 24-48 hours. No lasting fever past 24 hours of onset.

Maderna COVID-19 Vaccine EUA Got injection at 10:49 am Tuesday 3/9/21. At approximately 9:30 pm same day, started having chills and low grade fever of 99.3. Woke up around midnight with chills and body aches. Woke up at 5 am and was extremely fatigued. But fever was gone. Could barely get out of bed. Also had a headache. Able to go to work but left after being there for 45 minutes due to being dizzy, really fatigued, bad headache, and just sore all over. Got home and basically went to bed.

Mild headache and nausea about 30 minutes after injection. In middle of night had pain and swelling in left eye (same side of body as injection), left arm pain the next day.

sudden fever spike followed by intense vomiting/dry heaves which lasted most of the day but has eased in the day following...

Fatigue, nausea, vomiting and aches and pains in chest area similar to feeling when I had Covid19. This lasted for about 15 hours

About 15 minutes after the injection approx 10:55am I started felling light headed and slight dizziness, Its now 3:00 pm still a little light headed, flushed and feeling tired. I've not done any treatment for the symptoms

First Moderna shot- about 2 hours after shot developed symptoms. Body aches, headaches, and chills for the first 24 hours. After the symptoms eased up, I came down with a rash over more than half of my body

Full body aches, chills, sweats, fatigue and dizziness. Body aches, chills and sweats lasted around 20 hrs. Fatigue and diziness on and off 48rs

Several hours after the vaccination, my back started itching. The itching lasted that evening and into the next morning and then subsided - no treatment done. No rash. Also had fatigue the entire day after the vaccination. My right arm was sore.

Severe arm pain at and around the injection site 6 hours after the injection. Nausea and slight headache during the night at about 3:00 AM that went away in a couple of hours. Arm pain persisted the next day. The following day the pain also involved the armpit, possibly lymph glands. Lesser pain at the injection site and arm pit areas the following day and was very slight the third day after the injection. Can?t wait for my second dose and despite the side affects will happily stand in line for my next dose.

intermittent headache and blood pressure is erratic sometimes going as high as 170/130. Eye floaters and eye flashes and high BP caused ER visit on Sunday 3/14/2021.

Exstreme chills and body shaking for over 1 hour at 2 am next morning. Complete body ache all over. Headache and sick to stomach with no vomiting. Cold chills off and on for 2 days and very fatigue.

Patient wife called clinic at 1156 am. Patient lethargic, too weak to stand or walk, dry heaves. Advised to call 911 and take to ER. Called patient 3/17 for details. States on 3/4/21 in the evening, he developed HA, chills, and body aches. 3/5/21 took a shower and became light-headed, near-syncope or syncopal episode reported by patient. Wife gave him a Zofran ODT, which relieved the dry heaves. He rested remainder of day. Felt mostly better by 3/7/21, with remaining fatigue until 3/9/21.

The next morning I had a low grade fever with some fatigue that subsided by the evening. Next morning I was completely fine. But approximately one week later I developed rashes on the back on my neck and both wrists. They aren't conspicuous, but they do itch. I've had them for about two - three days. The rashes are slowly subsiding.

3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself. Pain is substernal, radiated to the left arm, associated with lightheadedness. Denies diaphoresis or nausea. Per EMS there were short runs of nonsustained ventricular tachycardia 3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia. He states he was lifting a couch yesterday and his heart started beating fast. He did not really have any chest pain, but felt a little bit lightheaded. He called an ambulance and they brought into the ER. In the emergency room his EKG did show some frequent PVCs. However, he did not really require any intervention. He was given 3 nitro, but it really did not make any difference in the way he was feeling. The patient denies multiple times that he actually had chest pain. He states he just felt like his heart was beating funny. The patient's most recent stress test was a nuclear stress test in May of 2019. Overnight, the patient has felt very well. He denies any significant chest pain. He denies any further heart palpitations. On the monitor he would occasionally going to bigeminy, which is not abnormal for him. EKG this morning was unremarkable. After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion. She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out. She states last night he was extremely diaphoretic and very nearly passed out.

Day 1 Arm soreness; Day 2 - alternating times of trembling/chill with fever conditions throughout the day. After 5PM mainly 101 fever, tired, muscle aches, headcahes, chills, hair follicles hurting ( had this when I had COVID-19 mid-March 2020); My symptoms from the 1st shot brought back memories of how the COVID-19 virus felt, except I did not have the congestion and sinus issues. Fever broke at 3AM morning of March 13, woke up soaking wet, entire body and hair drenched as if I stepped out of the shower, did not dry off and got into bed. Felt fatigued Day 3 but feeling a lot better, able to be more active. Today is March 19, 8 days since shot #1 and my arm at the Vaccine site is still a bit sore, redness has subsided however. Worried post shot 2 may be worse.

48 hours after vaccination, I experienced majority of side effects, fever, chills fatigue, headache, sniffles, sore arm where shot administered,etc. side effects only lasted 48 hours except for arm, it was sore 3 days.

Muscle and joint aches, fever (100.8), chills, extreme fatigue lasting for approximately 16 hours. Treated with Tylenol

some pain at the injection site tiredness headache body aches joint aches I felt bad for around 18 to 24 hours the folling day i didn't feel great, but not bad either

illness onset 1 day post vaccine (headache, fever, chills, aches) Severe body rash and Prurtus appearing over multiply locations on the torso, back, head, legs and arms approximately 2 weeks after second (2nd) Moderna vaccination shot. Other symptoms include headache, fatigue, dizziness, asthenia, Current course of treatment prescribed for rash is Prednisone 20mg. Symptoms as yet NOT resolved.

Shoulder pain at injection site that resolved over 48 hrs; mild chills and fatigue that resolved within 24 hrs.

shoulder became very sore several hours after injection, to the point where I could barely lift my arm, lasted about 48hours. also about 8 hours after injection got chills, slight fever and body aches which lasted about 36 hours

In November of 2020 I was diagnosed with COVID 19 and subsequently recovered. This was my first Moderna shot. I took the shot in the right arm and completed my work day with no side effects. I went to the gym that night - as usual - and wanted to "work that arm" a little. I had a good workout, no issues. Went home, ate and went to bed. About 1 or 2 am I woke up with the hottest raging inferno flu-like fever I can recall having as an adult. I did not want to alert my wife, so I simply stayed in bed and did not measure my fever level. My guess is it was >102. Fever continued until a.m. and deep body pain hit me. At dawn my fever measured 101. I took acetaminophen and took a cold shower. Fever subsided for a short while. Then it came back. I felt weak and flu-pain so I stayed home from work and simply slept it off. Symptoms slowly subsided by 7pm day 2. Day 3 I was not 100% but I went to work and was fine. No other symptoms since.

ARM was hurting for 3 weeks, blisters on the upper arm vaccine area, rash on the entire right arm, full torso and and both legs, short of breath, shivers, fever and body ache for 2 weeks. This lasted from March 10th through March 20th

A mild itching and swelling of my throat that lasted about an hour. This reaction happened within five minutes of getting the shot.

Pt received 1st moderna vaccine on 3/15/2021 and was admitted with sudden hypoxia , sob , low grade fever and pleuritic chest pain 10 days later. Pt is lifelong non smoker. no recent travel or recent illness. no new medications.

rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering. The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam. On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection. On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

On 2-24-21 I received my first dose lot #030M20A and had flu like illness the following day that lasted all day. The 2nd dose I started to feel bad that afternoon , I didn't sleep at all that night running a fever, cold chills, my body was sore and ached,restless, headache , and very weak. If I knew this is how I would had felt I would have never got the shot! And I will never again it was that bad.

Fever of 102 all day. Nausea, but never vomited. Was in bed sleeping All day. Recovered the following day, 3-26-21

Had shot Tuesday, Woke up Wednesday felt ok until about 10:00 A - got worse throughout the day, got home from work with 101 fever. and severe chills. Arm felt like it was beat with a baseball bat. 102 fever thru the night and severe body aches. Felt like I had Covid all over again. Sick all day Thursday with the same symptoms, Friday morning was better and fever again Friday night. Today has been somewhat better. Still not much strength.

No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fatigue. No fever. Loss of appetite. Soreness at injection site which spread from shoulder to elbow of left arm. Chills. Poor night's sleep with most symptoms continuing in morning.

Fever, chills, headache, fatigue and soreness in the arm where I got the shot; started feeling worse about 8 hours after getting the vaccine. Lasted about 36 hours.

Started to feel a little different in the first 8 hours. Then the next 10 hours I got a headache in the front of my head & the back of my neck. Chest pain when I had to cough. My whole body ached & slept for the next 12-16 hours. I started to feel better after 48 hours from the shot. All I did was drink plenty of water & eat bananas & apples & blueberries, just like I did when I had Covid-19 back in first week of November 2020. The only difference between the shot & having Covid-19 is I slept for almost 96 hours with Covid-19.

Pt received first Moderna COVID-19 vaccine on 3/15/21. Starting 3/27, patient began to have acute onset dizziness, muffled hearing, loss of consciousness and sinus congestion. On 3/28, this dizziness lead to a fall in which he hit his head and was sent to the ED. Pt tested positive for COVID 19 while in the ED, and was admitted.

Pt called pharmacy questioning if and when he should receive the 2nd dose as he is scheduled this Friday to receive it. However, he claims about 6 to 8 hours after 1st vaccination, he had experienced extreme shooting pain all over his upper torso and head, which resulted in an ER visit. Pt is still experiencing this pain, but not to the degree as before. He states he is enrolled in a clinical trial for a new medicine treating amyloidosis, which had just began 4 days prior to his vaccination on 3/5.

Patient reported pain in center of black and vision blurry approximately 10 -15 min. Patient with poor color and sweaty. Patient Pulse OX 77% , HR 50. 1555 - Epinephrine 0.3mg administered IM left thigh. Oxygen (full face mask) applied at 15L. Patient pulse ox 98%. Patient report still feeling poorly. 1402 - Benadryl 100 mg IM Right Deltoid administered. 1406 - B/P - 125/82 Pulse Ox 98% HR - 56 Oxygen slowly decreased to 5 L. EMS transported to ER

102 F temperature this morning. Taken with two different oral thermometers. Temp has now subsided to 99.5 F. Chills. headache, nausea, painful site injection arm, lethargy.

vaccine recieved 3/29/21, on 3/30/21 patient expired in his home. cause of death assumed to be cardiac related. Pt. was not feeling well after covid vaccination, therefore refused to go to dialysis (3/30/21). Collapsed in basement and was found by spouse 30 minutes later. Patient was DNR. spouse stated she feels death was not directly related to vaccine because he had several health conditions in which he has been noncompliant with and has not been following his medical providers treatment plans.

Mid-grade fever 100.6, chills, lower back ache (3) hours after 2nd shot March 29, 2021 at 3:30 p.m. EST. Symptoms lasted for 4 hours after taking 1000mg of Tylenol March 30, 2021- Mid-grade fever of 100.5, chills, lower back ache, (24) hours after 2nd shot. Symptoms lasted exactly (4) hours again after taking 1000mg Tylenol. This is Wednesday March 31st and am hoping for no more. Note: No symptoms in between fever and chills.

No issues first 48 hours, however on day 3 Fever, fatigue, headache and Rash on chest/back and face developed. Felt run down with alternating chill and sweating for next 3 days then subsided but chills and fatigue remained for addiotnal 2 days. On Day 8 felt mostly back to normal. I almost never get sick. I get Flu shots every year. I am very active and in excellent condition for my age. My wife says I have a very strong immune system and was worried this would happen. I suspect I may have been exposed to Covid earlier this year and that is why the delayed strong reaction. My wife does not want me to get the second shot.

Chills fever for 36 hours. Sever sinus headache 36 hours. Flu-like body pain 36 hours. In-bed for 36 hours. Nausea, no appetite.

fever (38.1oC), shivers - starting some 10hrs after injection, and then lasting for approx. 20hrs "vaccine arm" 6" dia. around injection site starting on 4/2/21

Started experience what can be described as cold like symptoms 12 hours after vaccination. Next morning had full cold-like symptoms (chills, muscle aches, stuffy head, dizziness). The second day felt better but became nauseous after physical exercise. The third day felt better in the AM but then started experiencing nausea and cold-like symptoms prior to bed. Today, the nausea continues when I eat.

Body aches, strong head aches, heartburn, bloating, nausea, calmly, feel hot but no fever---for 3 days and counting

30 minutes after Vaccine developed fatigue that persisted until hospital admission as below. 9 days after Vaccine developed acute onset nausea with vomiting and diarrhea. The following day developed abdominal pain. Ultimately 11 days after admission was admitted to the hospital with acute pancreatitis with workup neg for any other etiology or reason.

Body aches, headache, severe chills, fever up to 101, light headed/dizzy all started about 12 hours after injection. The most significant side effects subsided within 12 - 15 hours after onset (about 24 - 27 hours after the inection. dull headache and light headed feeling went away about 36 hours after injection. No medical treatment was sought. I took two Advil on Friday morning (injection was 11:15 am Thursday), but did not take more because I read an article that suggested taking Advil and similar medications could negatively affect the anti body production.

Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

Pt received the first dose of the Moderna COVID-19 vaccine on 4/5/2021. On 4/14/2021, he tested positive for SARS-CoV-2 via PCR. On 4/21/2021 he was ill enough to go to the ED due to COVID symptoms and was admitted to the general medicine floor of our hospital.

received the vaccine on Monday 4/19/21 into his left arm Tuesday 4/20/21 he went to work but after lunch became extremely fatigued and achy, went home to sleep it off Wednesday 4/21/21 he woke up with right UE/LE numbness and weakness which persisted until Thursday 4/22/21 so sought medical attention

Patient received the moderna vaccine (1st dose). Shortly after was hospitalized for a potential MS flare and was treated with pulse dose steroids, discharged home. He then started to feel progressively fatigued and was readmitted to the hospital on 4/19/21 with a diffuse pneumonitis complicated by hypoxemic respiratory failure. He is currently being treated with IV steroids.

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

Left side of head fells like needles; Arm pain; Sleepiness and fatigue; Splitting headache on the left side of head/throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left side of head fells like needles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tuberculosis. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (Left side of head fells like needles) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing). At the time of the report, PARAESTHESIA (Left side of head fells like needles), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing) had not resolved. Concomitant medication was not reported. Treatment medication included paracetamol and oxycodone 5 mg. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company comment:This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and non serious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and nonserious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

COVID diagnosis; coughing; low oxygen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COUGH (coughing) (seriousness criterion hospitalization) and HYPOXIA (low oxygen) (seriousness criterion hospitalization). On 24-Feb-2021, the patient experienced COVID-19 (COVID diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Antibody test: negative (Negative) Negative. On 19-Feb-2021, Oxygen saturation: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not given. This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment drugs were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive. No concomitant medications reported by investigator. Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone. Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose

headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 This case was linked to MOD-2021-095577 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:

Chills, fever, headache, started about 9hrs after injection Fever peaked @ 100.8? injection site very sore. And continues to be sore. Fever broke the following day. Weakness, fatigue, headache persisted until afternoon of 1/1 2021

About 8 hours after injection, began to have flu like symptoms and they continually worsened into severe symptoms; body aches, fever, cough, tiredness. Took Tylenol for these symtoms.

2 hours after injection:- Sore arm. 12 hours-99 degree temp, elevated pulse, shivers. 14 hours-100 degree temp, elevated pulse (120 bpm), chills, persistent moderate headache, achy muscles, sore back. 24 hours-98 degree temp, head ache gone, just a worn out feeling, 36 hours-back to normal other than a very sore arm at injection site and a worn out feeling.

Patient began having headache and fatigue 12/29. Early morning of 12/30 patient reported severe chills. Felt better during the day of 12/30 with only a headache. Night of 12/30 patient reported severe chills again and wanted to call the doctor in the morning, but the felt better on 12/31. The night of 12/31 patient again had chills, but less severe (rated 3/10 on scale). Night of 1/1 patient reported slight hive like rash that went away with warm Epsom salt bath. 1/3 0100 patient woke up with severe hives down back of legs and lower back. Got into a hot tub to soak and once the patient got out he was standing at the sink and passed out. His wife got him back to bed. Around 0700 on 1/3 patient woke up to urinate and he passed out again. He states both times he passed out felt the same stating "I felt like I was going to vomit and then all of a sudden I couldn?t breath, almost like I was choked out."

CoughWheeze some mild congestion, scratchy throat post nasal drip Narrative: 12/29 Tested positive COVID

Moderate to severe muscle pain at injection site lasting 4-5 days. Overall body aches lasting 2 days. High Fever (over 101) with intermittent periods of chills and then sweating for 48 hours which turned into an nocturnal fever (100.1) the second 48 hours.

Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain

Experienced fever and chills since 11 PM. Is taking Tylenol currently. As of 1233 on 1/8/21, still febrile. Arm is sore. He is aching all over (general malaise). Feels like he is fighting the Covid infection again.

Arm was very sore for 4 days after vaccination. Have never had a sore arm from vaccinations in the past. At day 4 post vaccination, developed a cough and congestion -- had none previously. Now on day 9 post vaccination and it is tapering down.

Developed severe myalgias with profound tremors. Severe lower back pain in the area of the kidneys. Minimal temperature elevation. Frontal headache. All symptoms lasted approximately 16 hours. Arm pain persisted for 4 days.

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

Moderna COVID-19 Vaccine EUA Fever noted approximately 24 hours after vaccine (101 degrees at 8:00 on 12.Jan) Chills, tiredness, slight headache, joint pain (knees, hips, ankles, shoulders, fingers) Took Aleve for pain Fever was 101.5 at 7PM; took Advil/Tylenol Fever broke around 9PM (98.6)

WITHIN 11 HOURS AFTER INJECTION - BEGAN EXPERIENCING SLIGHT RASH OVER MOST OF BODY- SORENESS AND INFLAMMATION AT INJECTION SIGHT (LEFT ARM), CHILLS, SHIVERING, ABDOMINAL PAIN, RISING TEMPERATURE (MAX 100.8) MUSCLE/JOINT PAIN, AND VERY SEVERE HEADACHES, LASTING NOW FOR THREE DAYS.

Day 1 headache progressing to migraine and nausea, injection site pain Day 2 - 3 continued migraine with aura, nausea worsening, runny nose Day 4 abdominal cramping , migraine subsided to dull headache Day 5 abdominal cramping worsening and muscle soreness (abdomen and lower back) hurt to urinate. Day 6 - 7 abdominal cramping subsided general soreness lessened Day 8 recovered

Severe constant headache that has been lasting for 5 days so far along with nausea. Low body temperature in a range 94.5-97 degrees F. There has been unstable blood pressure.

patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken out of his sleep having difficulty breathing. He estimates this episode lasted 30 seconds- 1 minute. he drank a sip of water thinking that would help. He then had a second more severe episode that lasted about 2 minutes. "I could not breathe, it felt like I was under water". H stated that after the episodes he felt jittery and very fatigued the rest of the day. He stated that the second episode was the worst he had ever had and thought he was going to pass out. He is a nonsmoker with NKDA. He does have asthma. He is on an inhaler and has a rescue inhaler. He stated that his last episode was 3-4 months ago, but these episodes were different. " It was a bigger fight to breathe". On 1/18/2021 at 2100 He had another episode that lasted 1-2 minutes. He used his inhaler, and improved. He was weak and dizzy after this episode and was unable to go to work.

Severe pain in left arm now 48 hrs after shot. Fever on 2 consecutive nights - bedding and pillows soaking wet. No appetite - headaches.

Very drowsy 6 hours after injection until 48 hours after injection. Diarrhea 18-26 hours after injection. Feel normal48 hours after injection.

Patient received Covid- 19 vaccine on 1/15/2021 at 5.15pm. On the 1/16/2021 around 8.35pm, he had chills and required assistance for walking and up on nurse assessment his temperature noted to be 101.9 F. nurse administered Tylenol 650mg and fluids were given. Up on follow up assessment of nurse on 1/17/2021 at 1.03am, the repeat temperature was 103.6F per ear probe. Due to high fever the 911 was called and was taken to ER. Normal assessment per ER evaluation and discharged to center with the diagnosis of vaccine reaction without any labs or chest x ray. Up on return to center, his temperature was 101F around 3.45 am on 1/17/2021, he was placed on increased oral fluids and Tylenol given as needed basis for fever. No more spiking of fever noted after that. He was hospitalized for Covid - 19 pneumonia from 11/6/2020 to 11/20/2020 at center, during the hospitalization he had intermittent spiking of temperature [101f-102F]. He had prolonged hospitalization due to intermittent fevers only and did not require ICU care. His work up was negative for infection other than Covid -19 infection and received broad spectrum antibiotics. He lives in facility for developmentally delayed individuals, due to group home setting & high risk of mortality in developmentally delayed [DD] population with Covid -19 infection - it was decided to vaccinate with Covid -19 vaccine after 2 weeks of Covoid -19 infection with they remain asymptomatic after 14 days of isolation with contact & droplet precautions.

Positive COVID -19 Lab result on 01/08/2021. Employee hospitalized due to COVID weakness, cough and shortness of breath. Admitted for 5 days.

10:00 am - headache, pressure on frontal lobe 2:00 pm - headache excruciating, weakness in legs, nausea 2:35 pm - blood pressure 198/97 2:40 pm - severe headache 3:00 pm - muscular aches all over body, overwhelming weakness 3:40 pm - vomited, had to pull over while driving home 3:50 pm - somewhat relieved after vomiting, arrived home stayed in car (parked) for over one hour to allow headache and weakness to subside 5 pm - entered apartment, took blood pressure, 137/77 5 pm - temperature normal (98.0 F) 5-9 pm - muscle weakness, headache.

Following vaccination, patient experienced lightheadedness, dizziness, headache and nausea. BP elevated. Blood sugar 315. Little improvement following rest in reclining position. Transferred to the hospital via ambulance. Next day, family reported patient was released from the hospital that evening and has resumed activity . No rash or wheezing noted during the episode. Telephone call to patient x2 for more information to complete VAERS but did not return my calls.

Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of appetite, chills, generalized discomfort, chest pain, difficulty breathing, and difficulty sleeping. All symptoms resolved with the exception of headache and difficulty sleeping until day 2 after receiving vaccination. Day 2 without symptoms

Patient received his second dose of COVID vaccine (Moderna) on 1/20/2021. Patient reported his joint stiffness symptoms about 8 hours after the vaccine. However, symptoms exacerbated on 1/24/2021. Patient endorses low grade fever and joint inflammation in the bilateral knees, finger stiffness, and left hip post vaccine. He notes hearing his right knee "pop," while he was walking. Patient was on crutches due to his pain and the popping noise of his knees. He notes symptoms have minimally subsided, however, his right knee continues to worsen. Patient notes his right knee feels like their is fluid in there. He didn't turn in his vaccine card due to not having a smart phone.

Reported having sinus congestion the day before getting the shot and symptoms continued since then without improvement or resolution.

Starting at 9:30pm I started having violent shaking and chills, Temperature 100, followed by severe body aches and profuse sweating throughout the night. By the following morning shakes and chills dissipated but body aches and fatigue persist with some light headedness and mild cold sweat.

Patient complained of diaphoresis and light headedness about 5 minutes after receiving 2nd dose of Moderna Covid vaccine. Patient was able to ambulate to cot. Blood pressure, heart rate, and respirations all within normal limits. Patient given water and observed for an additional 30 minutes. All symptoms resolved.

Staff member called to report an elevation in blood pressure (168/96) and pulse (103) with fever of 103.6F. Symptoms lasting into next day-was seen by his PCP with no additional follow-up needed.

Body felt normal with a little stiffness in neck. Felt tired and went to bed but in bed started experiencing chills. I put a heating pad on the bed and even though the bed and pad felt warm, the chills continued for about 10 minutes. Later in the night, my daughter came and checked my temperature. It was 105, even though I didn't feel like I had any fever. I took some Ibuprofen and my daughter put a cool damp cloth on my forehead. I never felt hot. In the morning, the area in the bed where I was sleeping was completely soaked! My temperature was normal.

Soreness at injection site (mild) and Fever 99.7 started about 6 hours after injection. Still feverish at bedtime, No fever next morning

The next day in the evening I experienced fever of 102 and I had chills, achiness in my body. I couldn't sleep, my thinking patterns were little confused, I was confused. I was also having adverse dreams. By Monday the fever went down, and the body aches and tiredness went down some. On Monday I went and got a COVID test and got a positive. Up to time of vaccination I have tested negative. The place that gave me the COVID test said it could be a false positive due to recently being vaccinated. The person from the COVID test said it was safe to get the 2nd dose. I feel okay right now and I am out and about.

Fever, shivering, temperature of 104, after taking 1000mg Tylenol, still had shaking/chills, headache, nausea temperature of 103. Took again 1000mg Tylenol. No information provided after Tylenol was taken.

After receiving Moderna vaccine, client became nauseous and diaphoretic. Laid down and lost consciousness. Came to within seconds. Denied any head injury or headaches. Complained of dizziness. O2 initiated 10L nonrebreather. Declined epinephrine. EMSA called. Client transported to hospital via EMSA for further evaluation.

Sir are immediately for 30 seconds, then around bedtime, very sore arm all night and most of Wednesday 2/3 and minor pain on 2/4 2/3 morning unsteady and queezy for 1/2 day Irritated throat 2/3 and 2/4, throat still still raw

36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection site, and severe diarrhea. The diarrhea lasted about 12 hours. I also felt general discomfort over entire body as if I had flu. This discomfort lasted for approximately 2 to 3 days. I was unable to perform normal activities during this time.

Took Tylenol after injection at approximately 9:30 AM on 26 January 2021; approximately 1:30 AM on 27 January 2021 was awakened by severe chills/tremors/ rigors (to the point it was difficult to hold a glass of water); took Tylenol and waited approximately 1.5 hours for chills and 100 deg. temp to subside. Took Advil at approximately 8:00 AM. Worked all day and at approximately 7:30 PM began having chills again and a fever of 101 deg. temp. Took Tylenol and temperature began lowering and I went to bed. Woke up again at approximately 1:30 AM 28 January 2021 with significant sweating. Took my temp and it was near normal. No further side effects/symptoms following this event.

The patient received his 2nd dose of covid vaccine on Monday 2/8/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 100.4 F. Since the patient was febrile, he received acetaminophen 650mg x1 at 7:46pm. The repeat temperature at 10pm was 98.8 F. He was not in distress. He had no complaints otherwise.

The day following vaccination, I started having lethargy, chills, lack of appetite, dull pain at injection site and sore neck and shoulders. by end of day, symptoms were as severe as when I had COVID last Nov. The next day, I felt fine, except for continuing site pain.

Chills early morning of 2/17/21. Severe headache joint and muscle pain throughout the day of 2/17/21

Chills started 9:00pm day of shot. Chills, headache and fever throughout the night. Following day of vaccine: Chills, fever 100.8 , slight headache

Flu like symtoms, body aches , joint pain. sleepy, chills, slight headache, enough to keep in bed all day

Sore arm at injection site (day of shot and next 2 days) Severe Gout flare up (10 pm day following shot and next few days) recovered - lingering Tiredness

Severe flu like symptoms, weakness, nausea, vomiting, muscle aches, dry throat, difficulty swallowing, 102 temperature

On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right arm., Unable to work. Seen by Concentra provider on 2/26/21. On 3/1/21, still feeling ill, unable to come to work.

1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER

Fever of 101, neck muscle pain, leg and back pain, dizziness starting 10 hours after second vaccination and lasting 26 hours (so far)

2/26/21 at 9am developed severe pain all over my entire body and every joint and extreme fatigue. Each day got a little better but lasted 3 days. No headache or fever.

Severe stabbing pain in lumbar spine for approximately 3hrs. Started 4 hrs after injection. Severe fatigue lasting for 3 days.

Next day about 11 am, began fatigue, chills, low grade fever. 99.8 to 100.3 slept most of the day. Vaccine sight was sore but no more than expected. All side effects have subside by this morning as I got up. Still tired but had a poor nights sleep with an episode of heavy sweating. Feeling fine now..

The evening after my vaccine, I had fever, chills and backpain for about 12 hours. the next evening my Scutum itched and then swelled up triple it's regular size for about 12 hours.

Moderna COVID-19 Vaccine EUA, mild headache, achiness in neck, injection site soreness. All for 36-42 hours from injection. Took 2 Tylenol before bed 2nd night.

Extreme Physical fatigue/Chills on second day(Friday) Saturday apprx 3A, like the rain stopping, I felt better. Some "Brain Fog" exists for next 5 days and continues.

I'm sick, like the second dose has made a lot of people. I began to feel soreness at the vaccine site about 08:00 pm. I began to feel like I was getting sick about 10:00 pm. I went to bed then, and woke up at 02:00 am, feeling like I had the flu -- body aches & feverish. Not horrible, but enough that I didn't feel like moving. I got up to go to the bathroom, and was uncovered, and then I got chilled. I went back to bed, and now at 07:30 am, I don't feel much better. My temperature is 100.6. It'a normally 96 to 97.

I left the vaccination feeling nothing at all. I awoke the next morning with a moderate pain/discomfort in my left upper arm at the vaccination site. I went to work because I felt okay. I have five years of recovery. As a result every 8-12 moths I undergo an episode of about three days where my brain forgets how to sleep properly. So the morning after my injection, I was on my second day of irregular sleep. Around 10 am, the side effects started kicking in. I had a slight to moderate pain above my ear on the right side of my head. I probably had a slight fever as I felt warm and sweaty for about four hours. I felt slight to moderate chills during the height of my discomfort for about four hours. I could hardly walk the five blocks to my girlfriend's home because I was very conscious of my breathing. (I have been a heavy cigarette smoker for 4o years and an developing a heightened awareness of my breathing and pulse as I feel that I am overdue for a stroke or heart attack after 40 years of heavy smoking.) Therefore his side effect was largely hypochondriacal. I took off work yesterday even though the side effects had subsided. Today, I feel great. I feel so great that I laughed at the entry below - "Patient Died".

Heavy chest pain, trouble breathing, fatigue on day following vaccine. Symptoms of chest pain remain but have lessened.

The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing.

Same symptoms as COVID-19 illness but more intense than the disease Headache, myalgias, fever, fatigue, chills Began less than 24 hours following second vaccine and lasted about 24 hours

Over 100 degree fever, chills, achy. Achiness started in evening. Fever and chill started around midnight lasting around 24 hours. Fever, chill subsided late on 3/11. Better but still achy on 3/12.

I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion

Severe headache...nausea...dizziness..severe joint pain..uncontrollable body temps from cold to hot over and over

On 3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital. ER dr name unknown so provided family dr nane

I experienced body aches and major fatigue right after receiving the vaccine on 03-04-21. It was worse on the second day. On the third day my right hip area and right leg was very sore and tender to the touch and noticed a rash on my hip area. The rash spread all over my right leg and foot and the pain got worse. My toes and foot became numb. I took Tylenol and Aleve to relieve the pain for a few days however I did not improve for a week. I visited an emergency care on 03-13-21 and was diagnosed with Shingles and I was prescribed Famiclovir. I started taking the meds as of yesterday and I am still experiencing pain all over my leg and numb foot.

I normally have an a1c value of 5.9 My blood sugar went up to 275 and I had to take triple the amount of insulin to bring it down. My blood sugar is still elevated 1 week after the shot, although not at 275 now. Headaches and sleeplessness

Eight minutes after the shot, I started felling unwell so I started my Apple Watch to see my heart rate. It was at 86 and a minute later it was at 116 and a minute after that it peaked at 119. It fell to mid 90's a couple minutes later, then went up to 105 fell back to mid 90s, then rose to 117, fell back to 80, and kept rising and falling until about 3pm. The technician told me before my shot that it would be a few minutes as they had to do something the vaccine. I don't recall what she told me. I think she said they had to switch a vial or something. You'd have to ask her what happened before I had my shot. This morning I have tingling in my thumb, forefinger and middle finger in the arm I got the shot. I did sleep on the arm that had the shot .

Minor headaches started about 10:15 AM and Left arm started hurting at the injection site at 12:40 PM. I Felt tightness around the front of the face upper cheek bones nasal area and from face of head. That night I woke up about 3 AM with a sinus headache and sore left arm, Sunday evening around 9 o?clock my temperature climb to 99.0 I took a nap and when I woke up it had returned back to normal. Today 3/15/21 my left arm is now just tender

Severe vomiting, severe diarrhea, nausea, 99.1F temp. - started 03/11/2021 @ 09:00 - dissipated 03/11/2021 @ 16:00 Fatigue- started 03/11/2021 @ 09:00 Wife called primary doctor, doctor said if symptoms do not disappear in 12 hours go to emergency room. Since symptoms dissipated in 5 hours, pt did not go to emergency room.

Painful injection site, sick stomach, fever, earache, headache, After 24 hours from injection I developed a bloody taste in mouth, severe bloody nose.

Chills started within five minutes then within an hour fever of 104. Patient taken by ambulance to Hospital and patient diagnosed with sepsis and cellulitis and shortness of breath

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

I had night sweats starting on Day 2 thru Day 6. from 2 to 3 times per night I had to change my night shirt. On day 5 I woke up to fever blisters/cold sores under/in my nostrils and fever blisters around/inside the corners of my mouth.

4" x 6" swelling and redness around shot area generating temperature of 101 degrees two and three days after being administered, headache lasting 2 days, joint pain lasting one day

Fever, headache, generalized "achiness" for 36 hrs post vaccine beginning on 3/11/2021. Caller states that last night while walking, he experienced "bone pain" in left leg, foot began dragging and leg numbness from knee down. Denies any pain, reports that he was able to walk home. Caller states that he went home and went to sleep, woke up 1.5 hrs later and symptoms had resolved. No other symptoms. Advised to contact PCP. Also advised of s/s of needing emergent care, such as SOB, chest pain, and/or neuro changes

After 6pm my joints especially my knees started to ache. My normal temperature is 97.5. I had a low grade fever of 99.2 by 8:45pm, and felt cold for the next twelve hours. Right arm very sore, took a Naproxen Sodium 220mg at 8:15pm. Temperature dropped to 98.5 by 11pm. Still felt achy, chilled, and fatigued, in bed and asleep by 11:35pm. Slept till 9am the next day. Ate a light breakfast, and took 325 mg Acetaminophen. After lunch another Acetaminophen, and a nap from 3-5pm. Aches and chills persisted till bed time the next night. Broke a sweat in the early morning on the 18th. Felt okay the rest of the day and after.

Chills (big time, could not stop shaking), body ache, sore injection site/arm. Swelling of arm that got the shot. Treated with Tylonal and rest

Fever, chills, fatigue, nausea, diarrhea, itching all over (itching has resolved). All but chills and fatigue have resolved.

Vasal vagal response. Diaphoretic no SOB. Placed pt in Trendelenburg after BP stable patient able to stand and walk around. Wife states this happened before when the pt gave blood. Initial BP 61/43 , BP at D/C 121/60 D/C home stable

Upon waking on the third day after receiving the second dose of the Moderna vaccine, I've experienced vertigo/disorientation. This side effect has continued a second day causing me to notify my primary care provider and preparing this event report. Other side effects experienced after the second vaccination were soreness at the injection sight, mild fatigue, and slight fever which were all anticipated. These side effects have passed.

Moderna COVID- 19 Vaccine EUA: patient presents to the emergency department (ED) with shortness of breath, dizziness, abdominal pain, nausea, cough, malaise, and headaches. Symptoms started four days prior to arriving in the ED when shoveling snow. Three days prior to arriving in the ED patient received vaccination and reports fever and persistent shortness of breath ever since. Seen by primary care provider one day before presenting to the ED and prescribed prednisone but did not take it. Initial vital signs showed tachycardia, fever, tachypnea, and decreased oxygen saturations on room air. Physical exam noted faint wheezing. Patient placed on oxygen, received albuterol, ipratropium, and steroids with improvement. Patient discharged to home with steroids, inhalers, and oxygen.

3 days after vaccine --difucs throbbing pain back of head and down the back of the neck. Comes and goes. Tylenol does not help. Continues up to and including day of reporting.

Very sore arm for two days after initial injection. I felt warm but no high fever. I also felt like I had very low grade flu symptoms for about a day and a half (i.e. body aches and pains).

Chills and feeling freezing; Vomitting; Abdominal pain; Difficulty breathing; Fever; A spontaneous report, was received from a consumer (patient's wife), concerning her husband, a 64 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chills and feeling freezing (chills), vomiting, abdominal pain, difficulty breathing (dyspnoea) and fever (pyrexia). The patient's medical history included history of congestive heart failure; triple bypass surgery done in 2017. The patient received dialysis on (Mon, Wed, & Fri), and was on oxygen 24 hours a day. The patient has allergy to valsartan and morphine. No Relevant concomitant medications were reported. On 11 Mar 2021, approximately within one hour prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, while at home, within an hour of receiving the vaccine, the patient started to experience chills and feeling freezing. The patient was taken to the hospital. The patient also experienced vomiting, complained of chills, developed abdominal pain, and had difficulty in breathing. The patient was currently in the intensive care unit. The patient's carbon level was high, needed a pit line and under bypap. The patient also had developed fever. Treatment medications included unspecified antibiotics and bilevel positive airway pressure (BiPAP) given to the patient at the hospital. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of the events, chills and feeling freezing, vomiting, abdominal pain, difficulty breathing, fever were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

19 hours: left eye went dark, left leg muscle contraction, 21 hrs: major muscles seized for 15 minutes(felt like they were tearing from bone), Fever for next 12 hours

Fever over 101 degrees for 36 hours headache, chills and cough after 1 dose. Took Tylenol and Muscinex. Took about 48 hours for fever to subside and another day to feel better.

vomiting and diarrhea 4+ hours in duration fever of 99.7 extreme weakness and fatigue 16+ hours, (patient is still experiencing extreme weakness and fatigue at the time of this submission).

pt states he started getting nauseated, got the chills, sweating, body aches and pains. He says it made him very shaky and his teeth were chattering. He went to bed and suffered w/ his symptoms. On 3/25/2021 he says his symptoms seem to be improving. Pt sent his PCP a message about his symptoms.

Vertigo starting one day after vaccine and resolving spontaneously after 3 days, also had some sweating (did not check for a fever)

Lips and cheeks were numb and I had a headache and fever with body aches. It lasted two and one half days

Fatigue beginning a few hours after injection and lasting through most of the following day. No other symptoms noted.

Vaccine side effects included fever, headache, cough, dry throat, muscle pain, joint pain, gastrointestinal distress, abdominal pain, insomnia, arm pain, sweating, chills.